Trial Outcomes & Findings for Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma (NCT NCT03207243)
NCT ID: NCT03207243
Last Updated: 2020-03-02
Results Overview
Loss of asthma control is defined as: Asthma Control Questionnaire (ACQ-5) score increase from Baseline \>=0.5 point or pre-bronchodilator forced expiratory volume in 1 second (FEV1) decrease from baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral corticosteroid \[OCS\] and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 16 has been presented. Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) population consisted of all randomized participants who took at least 1 dose of study treatment and if participants experienced loss of asthma control, they were analyzed according to actual treatment at time of loss of control.
COMPLETED
PHASE2
165 participants
Up to Week 16
2020-03-02
Participant Flow
This was a randomized, double-blind, placebo-controlled, parallel-group multicenter study to assess the efficacy, safety and tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in participants with moderately severe asthma.
A total of 165 participants with moderately severe asthma were randomized to receive GSK3772847 or placebo.
Participant milestones
| Measure |
Placebo
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
|
Overall Study
COMPLETED
|
23
|
39
|
|
Overall Study
NOT COMPLETED
|
59
|
44
|
Reasons for withdrawal
| Measure |
Placebo
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Loss of Asthma Control
|
47
|
31
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Specified Withdrawal Criteria
|
7
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
51.8 Years
STANDARD_DEVIATION 11.74 • n=7 Participants
|
52.9 Years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese /East Asian/South East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) Population. Only those participants with data available at indicated time points were analyzed.
Loss of asthma control is defined as: Asthma Control Questionnaire (ACQ-5) score increase from Baseline \>=0.5 point or pre-bronchodilator forced expiratory volume in 1 second (FEV1) decrease from baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral corticosteroid \[OCS\] and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 16 has been presented. Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) population consisted of all randomized participants who took at least 1 dose of study treatment and if participants experienced loss of asthma control, they were analyzed according to actual treatment at time of loss of control.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=70 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With Loss of Asthma Control Over Weeks 0-16
|
81 Percentage of participants
|
67 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
The ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A change of \>=0.5 in score suggests a clinically important change in score. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=47 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline
|
39 Percentage of participants
|
30 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
Pulmonary function is measured by FEV1. FEV1 is the amount of air expired in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline is defined as the latest available pre-dose assessment (Day 1). Decrease from Baseline \>7.5 % in score suggests worsening of condition.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=47 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 %
|
63 Percentage of participants
|
68 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
Corticosteroid titration allows overall clinical evaluation of the participant's asthma status taking into account both lung function and symptom control. Inability to titrate inhaled corticosteroids indicates loss of asthma control.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=47 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS)
|
23 Percentage of participants
|
30 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=47 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Asthma Exacerbation
|
7 Percentage of participants
|
13 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 6Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points were analyzed.
Loss of asthma control is defined as: ACQ-5 score increase from Baseline \>=0.5 point or pre-bronchodilator FEV1 decrease from Baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral OCS and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 6 has been presented.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=72 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With Loss of Asthma Control Over Weeks 0-6
|
50 Percentage of participants
|
36 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
Time to loss of asthma control was analyzed using Kaplan-Meier analysis. In this analysis, participants were either be counted as an event or they were censored. An event is defined as participants who experience loss of asthma control during the study. Censoring is defined as participants who discontinued investigational product for reasons other than loss of asthma control. The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Participants who didn't experience loss of asthma control were also censored at day 113.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=47 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Time to Loss of Asthma Control
|
50 Days
Interval 29.0 to
NA indicates data could not be calculated due to insufficient number of participants with events.
|
96 Days
Interval 31.0 to
NA indicates data could not be calculated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization. Participants with clinically significant asthma exacerbation or inability to titrate FP indicated loss of asthma control.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=47 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate
|
25 Percentage of participants
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat (mITT) population consisted of all randomized participants who took at least 1 dose of study treatment and were analyzed according to the treatment they received \>=50% of the time.
Hospitalization is defined as an inpatient stay or least an overnight stay at the hospital or emergency ward for observation or other equivalent facility. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=78 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Number of Participants Experiencing Asthma Related Hospitalization During the Study Period
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat Population.
An event is defined as an on-treatment asthma-related hospitalization or emergency room visit and participants can contribute to more than one event. Rate is calculated as number of events \* 1000 divided by (number of participants in treatment group \* mean treatment exposure in years). Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=78 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Rate Per 1000 Person-years of Participants With Hospitalization
|
70.5 Events per person-year
|
0 Events per person-year
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Modified Intent-to-Treat Population.
The number of hospitalization or emergency room visit made by per participant due to loss of asthma control have been presented in category titles. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=78 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Number of Hospitalizations or Emergency Room Visits Per Participants
0
|
77 Participants
|
78 Participants
|
|
Number of Hospitalizations or Emergency Room Visits Per Participants
1
|
1 Participants
|
0 Participants
|
|
Number of Hospitalizations or Emergency Room Visits Per Participants
2
|
0 Participants
|
0 Participants
|
|
Number of Hospitalizations or Emergency Room Visits Per Participants
>=3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath \& wheeze) enquire about the frequency \&/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=73 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week9; n=30, 42
|
-0.93 Scores on a scale
Standard Deviation 0.713
|
-0.97 Scores on a scale
Standard Deviation 0.817
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week1; n=72, 73
|
-0.36 Scores on a scale
Standard Deviation 0.713
|
-0.48 Scores on a scale
Standard Deviation 0.685
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week2; n=67, 68
|
-0.53 Scores on a scale
Standard Deviation 0.666
|
-0.74 Scores on a scale
Standard Deviation 0.732
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week3; n=61, 61
|
-0.59 Scores on a scale
Standard Deviation 0.722
|
-0.78 Scores on a scale
Standard Deviation 0.663
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week4; n=54, 59
|
-0.69 Scores on a scale
Standard Deviation 0.733
|
-0.79 Scores on a scale
Standard Deviation 0.695
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week5; n= 42, 52
|
-0.80 Scores on a scale
Standard Deviation 0.839
|
-0.78 Scores on a scale
Standard Deviation 0.804
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week6; n=40, 48
|
-0.80 Scores on a scale
Standard Deviation 0.907
|
-0.93 Scores on a scale
Standard Deviation 0.692
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week7; n=34, 46
|
-0.92 Scores on a scale
Standard Deviation 0.710
|
-0.93 Scores on a scale
Standard Deviation 0.785
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week8; n=33, 44
|
-0.95 Scores on a scale
Standard Deviation 0.769
|
-1.00 Scores on a scale
Standard Deviation 0.755
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week10; n=29, 41
|
-0.97 Scores on a scale
Standard Deviation 0.820
|
-0.99 Scores on a scale
Standard Deviation 0.729
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week11; n=22, 38
|
-1.05 Scores on a scale
Standard Deviation 0.907
|
-1.07 Scores on a scale
Standard Deviation 0.770
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week12; n=23, 38
|
-0.88 Scores on a scale
Standard Deviation 1.134
|
-1.16 Scores on a scale
Standard Deviation 0.795
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week13; n=17,32
|
-1.40 Scores on a scale
Standard Deviation 0.860
|
-1.06 Scores on a scale
Standard Deviation 0.773
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week14; n=17, 31
|
-1.33 Scores on a scale
Standard Deviation 0.943
|
-1.14 Scores on a scale
Standard Deviation 0.820
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week15; n=17, 27
|
-1.22 Scores on a scale
Standard Deviation 0.874
|
-1.21 Scores on a scale
Standard Deviation 0.814
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Week16; n=12, 21
|
-1.15 Scores on a scale
Standard Deviation 1.102
|
-1.17 Scores on a scale
Standard Deviation 0.738
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath \& wheeze) enquire about the frequency \&/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A responder is defined as participants with change from Baseline of \<= -0.5 point at given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=73 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week1; n=72, 73
|
38 Percentage of participants
|
41 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week2; n=67, 68
|
46 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week3; n=61, 61
|
49 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week4; n=54, 59
|
59 Percentage of participants
|
61 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week5; n= 42, 52
|
62 Percentage of participants
|
65 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week6; n=40, 48
|
63 Percentage of participants
|
69 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week7; n=34, 46
|
74 Percentage of participants
|
65 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week8; n=33, 44
|
70 Percentage of participants
|
73 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week9; n=30, 42
|
70 Percentage of participants
|
71 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week10; n=29, 41
|
69 Percentage of participants
|
76 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week11; n=22, 38
|
64 Percentage of participants
|
79 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week12; n=23, 38
|
57 Percentage of participants
|
79 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week13; n=17,32
|
82 Percentage of participants
|
75 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week14; n=17, 31
|
71 Percentage of participants
|
74 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week15; n=17, 27
|
76 Percentage of participants
|
74 Percentage of participants
|
|
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Week16; n=12, 21
|
67 Percentage of participants
|
81 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on Health-related quality of life (HRQoL) of participants with Chronic Obstructive Pulmonary Disease (COPD). It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=52 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Week4; n=43, 52
|
-10.0 Scores on a scale
Standard Deviation 14.98
|
-7.0 Scores on a scale
Standard Deviation 11.41
|
|
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Week8; n=31, 42
|
-10.7 Scores on a scale
Standard Deviation 15.32
|
-7.2 Scores on a scale
Standard Deviation 17.08
|
|
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Week12; n=23, 35
|
-15.8 Scores on a scale
Standard Deviation 21.42
|
-12.9 Scores on a scale
Standard Deviation 14.91
|
|
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Week16; n=16, 26
|
-12.4 Scores on a scale
Standard Deviation 20.75
|
-16.5 Scores on a scale
Standard Deviation 18.51
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and 16Population: Modified Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). A responder is defined as a change from Baseline of \<= -4 at the given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=52 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)
Week4; n=43, 52
|
60 Percentage of participants
|
58 Percentage of participants
|
|
Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)
Week8; n=31, 42
|
61 Percentage of participants
|
67 Percentage of participants
|
|
Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)
Week12; n=23, 35
|
70 Percentage of participants
|
74 Percentage of participants
|
|
Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)
Week16; n=16, 26
|
69 Percentage of participants
|
88 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, 12, 14 and 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Pre-bronchodilator FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the latest available assessment prior to first dose (Day 1) and change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=66 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week2; n=64, 66
|
0.094 Liters
Standard Deviation 0.2359
|
0.089 Liters
Standard Deviation 0.2443
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week4; n=48, 56
|
0.074 Liters
Standard Deviation 0.3077
|
0.086 Liters
Standard Deviation 0.2325
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week6; n=38, 50
|
0.078 Liters
Standard Deviation 0.2610
|
0.135 Liters
Standard Deviation 0.3758
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week8; n=33, 45
|
0.049 Liters
Standard Deviation 0.2888
|
0.089 Liters
Standard Deviation 0.2236
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week10; n=33, 43
|
0.047 Liters
Standard Deviation 0.2563
|
0.066 Liters
Standard Deviation 0.2372
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week12; n=23, 36
|
0.061 Liters
Standard Deviation 0.2759
|
0.037 Liters
Standard Deviation 0.2637
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week14; n=21, 36
|
0.079 Liters
Standard Deviation 0.2824
|
0.047 Liters
Standard Deviation 0.3200
|
|
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Week16; n=15, 26
|
0.063 Liters
Standard Deviation 0.3383
|
0.025 Liters
Standard Deviation 0.3008
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16.Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
PEF is maximum speed of expiration measured, using spirometer. The device was distributed to participants at Visit 1, to measure PEF twice-daily (morning upon waking \& in the evening just before going to bed). Participants were encouraged to perform morning \& evening PEF measurements before the use of any long-acting beta-agonists (LABAs) or rescue medication. Highest of 3 values were recorded in eDairy.Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mean PEF was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16).Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=77 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Morning PEF: Weeks 1-4,n=76, 76
|
4.13 Liters/minute
Standard Deviation 35.492
|
4.32 Liters/minute
Standard Deviation 43.773
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Morning PEF: Weeks 5-8,n=50, 56
|
-1.84 Liters/minute
Standard Deviation 65.222
|
-3.82 Liters/minute
Standard Deviation 46.621
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Morning PEF: Weeks 9-12,n=31, 43
|
-4.15 Liters/minute
Standard Deviation 46.588
|
-1.69 Liters/minute
Standard Deviation 45.192
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Morning PEF: Weeks 13-16,n=20, 38
|
-7.88 Liters/minute
Standard Deviation 47.190
|
-1.83 Liters/minute
Standard Deviation 69.866
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Evening PEF: Weeks 1-4,n=76, 77
|
0.43 Liters/minute
Standard Deviation 36.087
|
2.45 Liters/minute
Standard Deviation 37.712
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Evening PEF: Weeks 5-8,n=52, 58
|
-6.96 Liters/minute
Standard Deviation 61.987
|
-4.38 Liters/minute
Standard Deviation 49.076
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Evening PEF: Weeks 9-12,n=33, 44
|
-0.77 Liters/minute
Standard Deviation 54.768
|
-0.58 Liters/minute
Standard Deviation 39.929
|
|
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Evening PEF: Weeks 13-16,n=21, 38
|
-10.81 Liters/minute
Standard Deviation 51.566
|
-1.16 Liters/minute
Standard Deviation 63.383
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Asthma symptoms experienced by participants during the day was recorded in e-Diary every evening before going to bed in form of scores on a 5-point rating scale. Scores ranged from 0=no daytime asthma symptoms to 4=very severe daytime asthma symptoms. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean asthma symptom score was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=78 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period
Weeks 1-4, n=77, 78
|
-0.09 Scores on a scale
Standard Deviation 0.472
|
-0.02 Scores on a scale
Standard Deviation 0.337
|
|
Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period
Weeks 5-8, n=52, 59
|
-0.18 Scores on a scale
Standard Deviation 0.610
|
-0.09 Scores on a scale
Standard Deviation 0.460
|
|
Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period
Weeks 9-12 ,n=33,34
|
-0.29 Scores on a scale
Standard Deviation 0.631
|
-0.08 Scores on a scale
Standard Deviation 0.473
|
|
Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period
Weeks 13-16, n=21, 38
|
-0.29 Scores on a scale
Standard Deviation 0.692
|
-0.17 Scores on a scale
Standard Deviation 0.458
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
The mean number of inhalation of rescue medication (albuterol/salbutamol) used to relieve symptoms immediately during the day and night was recorded in eDiary from Baseline until Week 16. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean rescue medication use was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=75 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)
Weeks 1-4, n=78, 75
|
-0.52 Inhalations per day
Standard Deviation 2.554
|
-1.09 Inhalations per day
Standard Deviation 4.687
|
|
Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)
Weeks 5-8, n=56, 57
|
-0.52 Inhalations per day
Standard Deviation 1.740
|
-1.24 Inhalations per day
Standard Deviation 5.180
|
|
Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)
Weeks 9-12, n=32, 42
|
-0.17 Inhalations per day
Standard Deviation 0.945
|
-1.59 Inhalations per day
Standard Deviation 5.934
|
|
Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)
Weeks 13-16, n=24, 37
|
0.01 Inhalations per day
Standard Deviation 2.005
|
-1.90 Inhalations per day
Standard Deviation 6.624
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Participant captured night-time awakenings (yes/no) and use of rescue medication during these awakenings (yes/no) was recorded in e-Diary each morning. Percentage of night-time awakenings is calculated by number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data available\*100. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants having at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Night-time awakenings due to asthma symptoms requiring rescue medication was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=76 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use
Weeks 1-4, n=77, 76
|
-3.80 Percentage of nights with awakenings
Standard Deviation 25.712
|
-7.42 Percentage of nights with awakenings
Standard Deviation 23.847
|
|
Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use
Weeks 5-8,n=50, 56
|
-7.85 Percentage of nights with awakenings
Standard Deviation 26.325
|
-10.49 Percentage of nights with awakenings
Standard Deviation 31.081
|
|
Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use
Weeks 9-12,n=31, 43
|
-5.67 Percentage of nights with awakenings
Standard Deviation 24.669
|
-13.43 Percentage of nights with awakenings
Standard Deviation 26.962
|
|
Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use
Weeks 13-16,n=20, 38
|
-2.31 Percentage of nights with awakenings
Standard Deviation 30.355
|
-14.91 Percentage of nights with awakenings
Standard Deviation 33.544
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14 and 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
FeNO was assessed as a measure of airway inflammation using a handheld electronic device. The measurements recorded were according to standardized procedures by the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. FeNO measurements were obtained prior to FEV1 assessments. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is defined as the latest available assessment prior to first dose (Day 1). Percent change from Baseline is calculated as ratio to Baseline minus one and multiplied by 100. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=63 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week14; n=19, 30
|
28.1 Percent Change
Interval -43.0 to 483.0
|
1.7 Percent Change
Interval -48.0 to 457.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week1; n=60, 63
|
-3.6 Percent Change
Interval -46.0 to 126.0
|
-4.9 Percent Change
Interval -57.0 to 281.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week2; n=58, 59
|
15.4 Percent Change
Interval -57.0 to 481.0
|
0.0 Percent Change
Interval -66.0 to 206.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week4; n=41, 50
|
15.2 Percent Change
Interval -64.0 to 302.0
|
3.3 Percent Change
Interval -69.0 to 546.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week6; n=34, 46
|
5.0 Percent Change
Interval -71.0 to 537.0
|
0.0 Percent Change
Interval -62.0 to 221.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week8; n=29, 38
|
15.9 Percent Change
Interval -60.0 to 548.0
|
-2.9 Percent Change
Interval -40.0 to 148.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week10; n=29, 37
|
13.8 Percent Change
Interval -54.0 to 483.0
|
0.0 Percent Change
Interval -52.0 to 252.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week12; n=19, 31
|
31.4 Percent Change
Interval -40.0 to 422.0
|
8.8 Percent Change
Interval -47.0 to 413.0
|
|
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Week16; n=13, 22
|
85.9 Percent Change
Interval -33.0 to 635.0
|
12.7 Percent Change
Interval -51.0 to 695.0
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Population consists of all randomized participants who took at least 1 dose of study treatment.
A non-SAE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment were categorized as SAE.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
non-SAE
|
20 Participants
|
19 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
SAE
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
DBP and SBP were measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Post-dose: Week0; n=82, 83
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 8.05
|
1.3 Millimeters of Mercury (mmHg)
Standard Deviation 7.19
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week1; n=79, 75
|
-0.9 Millimeters of Mercury (mmHg)
Standard Deviation 9.61
|
0.4 Millimeters of Mercury (mmHg)
Standard Deviation 9.67
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week2; n=73, 75
|
-1.3 Millimeters of Mercury (mmHg)
Standard Deviation 10.73
|
-1.3 Millimeters of Mercury (mmHg)
Standard Deviation 10.58
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Pre-dose: Week4; n=49, 59
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 8.88
|
-0.1 Millimeters of Mercury (mmHg)
Standard Deviation 8.84
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Post-dose: Week4; n=48, 59
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.46
|
2.2 Millimeters of Mercury (mmHg)
Standard Deviation 10.72
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP:Week6; n=45, 57
|
-1.7 Millimeters of Mercury (mmHg)
Standard Deviation 9.33
|
0.9 Millimeters of Mercury (mmHg)
Standard Deviation 9.38
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Pre-Dose:Week8; n=34, 47
|
-1.9 Millimeters of Mercury (mmHg)
Standard Deviation 7.85
|
0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.91
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Post-DoseWeek8; n=34, 47
|
-2.7 Millimeters of Mercury (mmHg)
Standard Deviation 9.81
|
2.3 Millimeters of Mercury (mmHg)
Standard Deviation 9.46
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week10; n=34, 46
|
-2.5 Millimeters of Mercury (mmHg)
Standard Deviation 10.20
|
0.7 Millimeters of Mercury (mmHg)
Standard Deviation 11.74
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Pre-dose: Week12; n=24, 39
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 8.34
|
1.5 Millimeters of Mercury (mmHg)
Standard Deviation 10.19
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Post-dose: Week12; n=24, 39
|
-0.7 Millimeters of Mercury (mmHg)
Standard Deviation 6.34
|
3.3 Millimeters of Mercury (mmHg)
Standard Deviation 11.23
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week14; n=24, 39
|
-1.6 Millimeters of Mercury (mmHg)
Standard Deviation 9.17
|
2.1 Millimeters of Mercury (mmHg)
Standard Deviation 10.47
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week16; n=24, 39
|
-2.8 Millimeters of Mercury (mmHg)
Standard Deviation 9.16
|
1.5 Millimeters of Mercury (mmHg)
Standard Deviation 10.37
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week20; n=76, 78
|
-1.0 Millimeters of Mercury (mmHg)
Standard Deviation 10.72
|
1.7 Millimeters of Mercury (mmHg)
Standard Deviation 10.32
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week24; n=75, 76
|
-2.4 Millimeters of Mercury (mmHg)
Standard Deviation 10.78
|
1.7 Millimeters of Mercury (mmHg)
Standard Deviation 10.46
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP: Week28; n=74, 77
|
-1.3 Millimeters of Mercury (mmHg)
Standard Deviation 9.95
|
1.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.77
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Post-dose: Week0; n=82,83
|
-0.7 Millimeters of Mercury (mmHg)
Standard Deviation 6.58
|
-0.3 Millimeters of Mercury (mmHg)
Standard Deviation 5.67
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week1; n=79, 75
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 6.96
|
0.7 Millimeters of Mercury (mmHg)
Standard Deviation 8.29
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week2; n=73, 75
|
-0.7 Millimeters of Mercury (mmHg)
Standard Deviation 8.61
|
-0.8 Millimeters of Mercury (mmHg)
Standard Deviation 7.04
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Pre-dose: Week4; n=49, 59
|
-1.1 Millimeters of Mercury (mmHg)
Standard Deviation 8.26
|
0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.72
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Post-dose: Week4; n=48, 59
|
-0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.93
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 7.79
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP:Week6; n=45, 57
|
0.6 Millimeters of Mercury (mmHg)
Standard Deviation 7.72
|
-1.0 Millimeters of Mercury (mmHg)
Standard Deviation 7.32
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Pre-Dose:Week8; n=34, 47
|
-0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.66
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 7.79
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Post-DoseWeek8; n=34, 47
|
-0.1 Millimeters of Mercury (mmHg)
Standard Deviation 7.54
|
-1.2 Millimeters of Mercury (mmHg)
Standard Deviation 7.21
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week10; n=34, 46
|
-0.1 Millimeters of Mercury (mmHg)
Standard Deviation 9.36
|
-0.2 Millimeters of Mercury (mmHg)
Standard Deviation 7.94
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Pre-dose: Week12; n=24, 39
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 7.27
|
0.6 Millimeters of Mercury (mmHg)
Standard Deviation 6.52
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Post-dose: Week12; n=24, 39
|
0.0 Millimeters of Mercury (mmHg)
Standard Deviation 8.08
|
-0.5 Millimeters of Mercury (mmHg)
Standard Deviation 6.79
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week14; n=24, 39
|
0.0 Millimeters of Mercury (mmHg)
Standard Deviation 5.28
|
0.5 Millimeters of Mercury (mmHg)
Standard Deviation 6.84
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week16; n=24, 39
|
-0.3 Millimeters of Mercury (mmHg)
Standard Deviation 8.37
|
-0.5 Millimeters of Mercury (mmHg)
Standard Deviation 5.59
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week20; n=76, 78
|
-0.4 Millimeters of Mercury (mmHg)
Standard Deviation 8.61
|
0.7 Millimeters of Mercury (mmHg)
Standard Deviation 6.60
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week24; n=75, 76
|
0.1 Millimeters of Mercury (mmHg)
Standard Deviation 8.15
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 7.06
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP: Week28; n=74, 77
|
-0.3 Millimeters of Mercury (mmHg)
Standard Deviation 9.74
|
-0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.62
|
SECONDARY outcome
Timeframe: Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Pulse Rate (PR)
Post-dose: Week0; n=82, 83
|
-2.2 Beats per minute
Standard Deviation 7.20
|
-0.1 Beats per minute
Standard Deviation 6.54
|
|
Change From Baseline in Pulse Rate (PR)
Week1; n=79, 75
|
0.8 Beats per minute
Standard Deviation 6.12
|
3.1 Beats per minute
Standard Deviation 7.95
|
|
Change From Baseline in Pulse Rate (PR)
Week2; n=73, 75
|
2.9 Beats per minute
Standard Deviation 7.31
|
1.7 Beats per minute
Standard Deviation 7.86
|
|
Change From Baseline in Pulse Rate (PR)
Pre-dose:Week4; n=49, 59
|
-0.3 Beats per minute
Standard Deviation 9.73
|
0.1 Beats per minute
Standard Deviation 9.72
|
|
Change From Baseline in Pulse Rate (PR)
Post-dose:Week4; n=48, 59
|
-2.0 Beats per minute
Standard Deviation 10.00
|
-1.0 Beats per minute
Standard Deviation 10.93
|
|
Change From Baseline in Pulse Rate (PR)
Week6; n=45, 57
|
3.3 Beats per minute
Standard Deviation 11.85
|
2.8 Beats per minute
Standard Deviation 9.26
|
|
Change From Baseline in Pulse Rate (PR)
Pre-dose: Week8; n=34, 47
|
-0.3 Beats per minute
Standard Deviation 9.11
|
1.0 Beats per minute
Standard Deviation 7.62
|
|
Change From Baseline in Pulse Rate (PR)
Post-dose: Week8; n=34, 47
|
-0.9 Beats per minute
Standard Deviation 10.39
|
-0.6 Beats per minute
Standard Deviation 9.71
|
|
Change From Baseline in Pulse Rate (PR)
Week10; n=34, 46
|
2.6 Beats per minute
Standard Deviation 8.86
|
2.4 Beats per minute
Standard Deviation 6.72
|
|
Change From Baseline in Pulse Rate (PR)
Pre-dose: Week12; n=24, 39
|
2.8 Beats per minute
Standard Deviation 8.04
|
1.7 Beats per minute
Standard Deviation 7.53
|
|
Change From Baseline in Pulse Rate (PR)
Post-dose: Week12; n=24, 39
|
0.9 Beats per minute
Standard Deviation 8.84
|
-1.2 Beats per minute
Standard Deviation 10.57
|
|
Change From Baseline in Pulse Rate (PR)
Week14; n=24, 39
|
3.1 Beats per minute
Standard Deviation 9.81
|
3.6 Beats per minute
Standard Deviation 6.62
|
|
Change From Baseline in Pulse Rate (PR)
Week16; n=24, 39
|
3.5 Beats per minute
Standard Deviation 9.14
|
2.6 Beats per minute
Standard Deviation 8.30
|
|
Change From Baseline in Pulse Rate (PR)
Week20; n=76, 78
|
2.1 Beats per minute
Standard Deviation 8.34
|
3.6 Beats per minute
Standard Deviation 9.48
|
|
Change From Baseline in Pulse Rate (PR)
Week24; n=75, 76
|
2.3 Beats per minute
Standard Deviation 8.00
|
2.5 Beats per minute
Standard Deviation 7.98
|
|
Change From Baseline in Pulse Rate (PR)
Week28; n=74, 77
|
2.5 Beats per minute
Standard Deviation 8.50
|
2.3 Beats per minute
Standard Deviation 7.98
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4, 8 and 12Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
DBP and SBP was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
SBP: Week0; n=82, 83
|
-2.0 mmHg
Standard Deviation 8.05
|
1.3 mmHg
Standard Deviation 7.19
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
SBP: Week4; n=48, 59
|
-0.4 mmHg
Standard Deviation 5.70
|
2.4 mmHg
Standard Deviation 9.32
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
SBP: Week8; n=34, 47
|
-0.8 mmHg
Standard Deviation 6.03
|
1.9 mmHg
Standard Deviation 6.58
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
SBP: Week12; n=24, 39
|
-0.9 mmHg
Standard Deviation 7.51
|
1.8 mmHg
Standard Deviation 8.72
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
DBP: Week0; n=82, 83
|
-0.7 mmHg
Standard Deviation 6.58
|
-0.3 mmHg
Standard Deviation 5.67
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
DBP: Week4; n=48, 59
|
0.4 mmHg
Standard Deviation 4.95
|
-0.1 mmHg
Standard Deviation 6.76
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
DBP: Week8; n=34, 47
|
0.2 mmHg
Standard Deviation 4.38
|
0.8 mmHg
Standard Deviation 5.55
|
|
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
DBP: Week12; n=24, 39
|
-0.3 mmHg
Standard Deviation 4.70
|
-1.1 mmHg
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4, 8 and 12Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
Pulse rate was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline Between Post-dose and Pre-dose in Pulse Rate
Week0; n=82, 83
|
-2.2 Beats per minute
Standard Deviation 7.20
|
-0.1 Beats per minute
Standard Deviation 6.54
|
|
Change From Baseline Between Post-dose and Pre-dose in Pulse Rate
Week4; n=48, 59
|
-1.6 Beats per minute
Standard Deviation 5.75
|
-1.1 Beats per minute
Standard Deviation 6.85
|
|
Change From Baseline Between Post-dose and Pre-dose in Pulse Rate
Week8; n=34, 47
|
-0.5 Beats per minute
Standard Deviation 7.21
|
-1.6 Beats per minute
Standard Deviation 6.02
|
|
Change From Baseline Between Post-dose and Pre-dose in Pulse Rate
Week12; n=24, 39
|
-2.0 Beats per minute
Standard Deviation 5.97
|
-2.9 Beats per minute
Standard Deviation 9.05
|
SECONDARY outcome
Timeframe: Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Pre-dose: Week4; n=49, 59
|
-1.7 milliseconds
Standard Deviation 21.48
|
-1.8 milliseconds
Standard Deviation 17.93
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Pre-dose: Week8; n=34, 47
|
3.5 milliseconds
Standard Deviation 23.67
|
-4.7 milliseconds
Standard Deviation 20.53
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT Pre-dose:Week12; n=24, 39
|
1.5 milliseconds
Standard Deviation 22.31
|
-3.1 milliseconds
Standard Deviation 23.54
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Week16; n=24,39
|
-2.2 milliseconds
Standard Deviation 21.15
|
-7.3 milliseconds
Standard Deviation 20.68
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Pre-dose:Week8; n=34, 47
|
6.4 milliseconds
Standard Deviation 13.00
|
-0.9 milliseconds
Standard Deviation 14.54
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Post-dose:Week8; n=33, 47
|
5.5 milliseconds
Standard Deviation 12.86
|
5.8 milliseconds
Standard Deviation 16.08
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Pre-dose:Week12; n=24, 39
|
3.3 milliseconds
Standard Deviation 13.45
|
0.4 milliseconds
Standard Deviation 17.56
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF: Week16; n=24, 39
|
-0.5 milliseconds
Standard Deviation 11.87
|
-2.2 milliseconds
Standard Deviation 14.83
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Pre-dose:Week8; n=34, 47
|
-17.4 milliseconds
Standard Deviation 135.17
|
-24.2 milliseconds
Standard Deviation 92.65
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Post-dose:Week8; n=33, 47
|
10.8 milliseconds
Standard Deviation 176.36
|
10.7 milliseconds
Standard Deviation 97.02
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Pre-dose:Week12; n=24, 39
|
-12.6 milliseconds
Standard Deviation 107.36
|
-21.6 milliseconds
Standard Deviation 100.97
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Post-dose:Week12; n=24, 39
|
-4.8 milliseconds
Standard Deviation 148.89
|
1.3 milliseconds
Standard Deviation 118.83
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Week16; n=24, 39
|
-14.4 milliseconds
Standard Deviation 113.07
|
-33.9 milliseconds
Standard Deviation 102.02
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Pre-dose: Week8; n=34, 47
|
0.0 milliseconds
Standard Deviation 8.69
|
1.4 milliseconds
Standard Deviation 11.70
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Post-dose: Week0; n=80, 80
|
1.8 milliseconds
Standard Deviation 9.77
|
3.1 milliseconds
Standard Deviation 9.28
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Pre-dose: Week4; n=49, 59
|
-0.4 milliseconds
Standard Deviation 7.91
|
1.3 milliseconds
Standard Deviation 10.93
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Post-dose: Week4; n=48, 59
|
1.2 milliseconds
Standard Deviation 9.74
|
1.9 milliseconds
Standard Deviation 11.76
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR:Post-dose: Week8; n=33, 47
|
0.5 milliseconds
Standard Deviation 11.47
|
1.5 milliseconds
Standard Deviation 11.30
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Pre-dose:Week12; n=24, 39
|
-1.3 milliseconds
Standard Deviation 9.51
|
-0.5 milliseconds
Standard Deviation 13.17
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Post-dose Week12; n=24, 39
|
1.3 milliseconds
Standard Deviation 10.85
|
2.2 milliseconds
Standard Deviation 12.59
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
PR: Week16; n=24, 39
|
-0.6 milliseconds
Standard Deviation 10.22
|
-0.7 milliseconds
Standard Deviation 12.91
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Post-dose Week0; n=80, 80
|
0.0 milliseconds
Standard Deviation 5.75
|
0.2 milliseconds
Standard Deviation 5.60
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Pre-dose Week4; n=49, 59
|
-0.5 milliseconds
Standard Deviation 5.69
|
0.7 milliseconds
Standard Deviation 5.72
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS: Post-dose:Week4; n=48, 59
|
-0.2 milliseconds
Standard Deviation 6.10
|
0.1 milliseconds
Standard Deviation 6.14
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Pre-dose:Week8; n=34, 47
|
0.2 milliseconds
Standard Deviation 5.86
|
-0.1 milliseconds
Standard Deviation 4.90
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Post-dose:Week8; n=33, 47
|
0.5 milliseconds
Standard Deviation 7.02
|
0.1 milliseconds
Standard Deviation 4.87
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Pre-dose: Week12; n=24, 39
|
-1.3 milliseconds
Standard Deviation 4.83
|
-1.1 milliseconds
Standard Deviation 7.13
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Post-dose: Week12; n=24, 39
|
-0.7 milliseconds
Standard Deviation 6.03
|
-1.8 milliseconds
Standard Deviation 6.21
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QRS:Week16; n=24, 39
|
-1.6 milliseconds
Standard Deviation 6.19
|
-2.0 milliseconds
Standard Deviation 6.25
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Post-dose: Week0; n=80, 80
|
7.4 milliseconds
Standard Deviation 19.67
|
3.5 milliseconds
Standard Deviation 16.69
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Post-dose: Week4; n=48, 59
|
8.9 milliseconds
Standard Deviation 23.09
|
5.1 milliseconds
Standard Deviation 18.78
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Pre-dose: Week8; n=33, 47
|
6.7 milliseconds
Standard Deviation 30.69
|
7.0 milliseconds
Standard Deviation 23.49
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QT:Post-dose:Week12; n=24, 39
|
3.3 milliseconds
Standard Deviation 24.38
|
2.4 milliseconds
Standard Deviation 23.16
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Post-dose:Week0; n=80, 80
|
4.2 milliseconds
Standard Deviation 12.56
|
3.8 milliseconds
Standard Deviation 11.21
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Pre-dose:Week4; n=49, 59
|
-1.4 milliseconds
Standard Deviation 11.35
|
-1.0 milliseconds
Standard Deviation 12.10
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Post-dose:Week4; n=48, 59
|
4.0 milliseconds
Standard Deviation 13.57
|
2.0 milliseconds
Standard Deviation 12.46
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
QTcF:Post-dose: Week12; n=24, 39
|
4.4 milliseconds
Standard Deviation 13.91
|
2.9 milliseconds
Standard Deviation 14.33
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Post-dose: Week0; n=80, 80
|
24.0 milliseconds
Standard Deviation 104.42
|
-0.2 milliseconds
Standard Deviation 89.38
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Pre-dose: Week4; n=49, 59
|
-1.3 milliseconds
Standard Deviation 114.81
|
-2.0 milliseconds
Standard Deviation 96.20
|
|
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
RR:Post-dose: Week4; n=48, 59
|
36.2 milliseconds
Standard Deviation 118.51
|
26.7 milliseconds
Standard Deviation 110.84
|
SECONDARY outcome
Timeframe: Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in ECG Heart Rate
Post-dose: Week0; n=82, 83
|
-1.6 Beats per minute
Standard Deviation 7.57
|
0.2 Beats per minute
Standard Deviation 6.93
|
|
Change From Baseline in ECG Heart Rate
Pre-dose: Week4; n=49, 59
|
0.4 Beats per minute
Standard Deviation 9.06
|
0.7 Beats per minute
Standard Deviation 7.94
|
|
Change From Baseline in ECG Heart Rate
Post-dose: Week4; n=48, 59
|
-2.4 Beats per minute
Standard Deviation 9.09
|
-1.0 Beats per minute
Standard Deviation 8.48
|
|
Change From Baseline in ECG Heart Rate
Pre-dose: Week8; n=34, 47
|
1.5 Beats per minute
Standard Deviation 11.81
|
1.9 Beats per minute
Standard Deviation 6.98
|
|
Change From Baseline in ECG Heart Rate
Post-dose: Week8; n=33, 47
|
-0.3 Beats per minute
Standard Deviation 15.59
|
-0.4 Beats per minute
Standard Deviation 7.57
|
|
Change From Baseline in ECG Heart Rate
Pre-dose:Week12; n=24, 39
|
0.6 Beats per minute
Standard Deviation 8.98
|
1.6 Beats per minute
Standard Deviation 7.56
|
|
Change From Baseline in ECG Heart Rate
Post-dose Week12; n=24, 39
|
0.4 Beats per minute
Standard Deviation 12.44
|
0.5 Beats per minute
Standard Deviation 9.28
|
|
Change From Baseline in ECG Heart Rate
Week16; n=24, 39
|
0.5 Beats per minute
Standard Deviation 10.04
|
3.1 Beats per minute
Standard Deviation 8.12
|
SECONDARY outcome
Timeframe: Baseline and Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Triplicate 12-lead ECGs were recorded with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in QRS Axis
Post-dose: Week0; n=80, 80
|
-0.8 Degrees
Standard Deviation 10.76
|
1.9 Degrees
Standard Deviation 6.75
|
|
Change From Baseline in QRS Axis
Pre-dose: Week4; n=49, 59
|
0.7 Degrees
Standard Deviation 14.30
|
2.3 Degrees
Standard Deviation 13.77
|
|
Change From Baseline in QRS Axis
Post-dose: Week4; n=48, 59
|
-0.1 Degrees
Standard Deviation 16.72
|
1.4 Degrees
Standard Deviation 11.95
|
|
Change From Baseline in QRS Axis
Pre-dose: Week8; n=34, 47
|
-0.2 Degrees
Standard Deviation 10.56
|
-1.0 Degrees
Standard Deviation 9.34
|
|
Change From Baseline in QRS Axis
Post-dose: Week8; n=33, 47
|
1.0 Degrees
Standard Deviation 9.88
|
-1.2 Degrees
Standard Deviation 8.37
|
|
Change From Baseline in QRS Axis
Pre-dose:Week12; n=24, 39
|
0.2 Degrees
Standard Deviation 8.59
|
2.0 Degrees
Standard Deviation 31.39
|
|
Change From Baseline in QRS Axis
Post-dose Week12; n=24, 39
|
-1.3 Degrees
Standard Deviation 9.49
|
-1.2 Degrees
Standard Deviation 15.73
|
|
Change From Baseline in QRS Axis
Week16; n=24, 39
|
2.3 Degrees
Standard Deviation 11.35
|
-1.4 Degrees
Standard Deviation 10.88
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4, 8 and 12Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QRS:Week12; n=24, 39
|
0.7 milliseconds
Standard Deviation 5.36
|
-0.9 milliseconds
Standard Deviation 4.60
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
PR:Week0; n=80, 80
|
1.8 milliseconds
Standard Deviation 9.77
|
3.1 milliseconds
Standard Deviation 9.28
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
PR: Week4; n=48, 59
|
1.7 milliseconds
Standard Deviation 8.04
|
0.5 milliseconds
Standard Deviation 9.77
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
PR: Week8; n=33, 47
|
0.3 milliseconds
Standard Deviation 8.70
|
-0.1 milliseconds
Standard Deviation 9.96
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
PR: Week12; n=24, 39
|
2.2 milliseconds
Standard Deviation 10.00
|
3.0 milliseconds
Standard Deviation 9.86
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QRS:Week0; n=80, 80
|
0.0 milliseconds
Standard Deviation 5.75
|
0.2 milliseconds
Standard Deviation 5.60
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QRS: Week4; n=48, 59
|
0.1 milliseconds
Standard Deviation 4.35
|
-0.8 milliseconds
Standard Deviation 5.58
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QRS:Week8; n=33, 47
|
0.3 milliseconds
Standard Deviation 7.03
|
0.4 milliseconds
Standard Deviation 4.86
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QT:Week0; n=80, 80
|
7.4 milliseconds
Standard Deviation 19.67
|
3.5 milliseconds
Standard Deviation 16.69
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QT:Week4; n=48, 59
|
10.8 milliseconds
Standard Deviation 13.32
|
6.9 milliseconds
Standard Deviation 15.63
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QT:Week8; n=33, 47
|
3.4 milliseconds
Standard Deviation 19.22
|
11.5 milliseconds
Standard Deviation 17.57
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QT:Week12; n=24, 39
|
1.9 milliseconds
Standard Deviation 17.17
|
4.6 milliseconds
Standard Deviation 18.77
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QTcFWeek0; n=80, 80
|
4.2 milliseconds
Standard Deviation 12.56
|
3.8 milliseconds
Standard Deviation 11.21
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QTcF:Week4; n=48, 59
|
5.4 milliseconds
Standard Deviation 9.51
|
2.9 milliseconds
Standard Deviation 10.88
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QTcF:Week8; n=33, 47
|
-0.7 milliseconds
Standard Deviation 10.17
|
6.6 milliseconds
Standard Deviation 10.65
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
QTcF:Week12; n=24, 39
|
1.1 milliseconds
Standard Deviation 13.28
|
2.0 milliseconds
Standard Deviation 13.48
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
RR:Week0; n=80, 80
|
24.0 milliseconds
Standard Deviation 104.42
|
-0.2 milliseconds
Standard Deviation 89.38
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
RR:Week4; n=48, 59
|
37.6 milliseconds
Standard Deviation 83.83
|
29.5 milliseconds
Standard Deviation 88.38
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
RR:Week8; n=33, 47
|
29.3 milliseconds
Standard Deviation 97.67
|
34.4 milliseconds
Standard Deviation 95.05
|
|
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
RR:Week12; n=24, 39
|
8.8 milliseconds
Standard Deviation 83.16
|
20.7 milliseconds
Standard Deviation 104.02
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4, 8 and 12Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change Between Pre-dose and Post-dose of Heart Rate
Week0; n=80, 80
|
-1.6 Beats per minute
Standard Deviation 7.57
|
0.2 Beats per minute
Standard Deviation 6.93
|
|
Change Between Pre-dose and Post-dose of Heart Rate
Week4; n=48, 59
|
-2.9 Beats per minute
Standard Deviation 5.79
|
-1.7 Beats per minute
Standard Deviation 6.15
|
|
Change Between Pre-dose and Post-dose of Heart Rate
Week8; n=33, 47
|
-1.8 Beats per minute
Standard Deviation 8.74
|
-2.3 Beats per minute
Standard Deviation 6.83
|
|
Change Between Pre-dose and Post-dose of Heart Rate
Week12; n=24, 39
|
-0.2 Beats per minute
Standard Deviation 6.69
|
-0.9 Beats per minute
Standard Deviation 7.75
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4, 8 and 12Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change Between Pre-dose and Post-dose of QRS Axis
Week0; n=80, 80
|
-0.8 Degrees
Standard Deviation 10.76
|
1.9 Degrees
Standard Deviation 6.75
|
|
Change Between Pre-dose and Post-dose of QRS Axis
Week4; n=48, 59
|
-0.3 Degrees
Standard Deviation 9.20
|
-0.9 Degrees
Standard Deviation 16.22
|
|
Change Between Pre-dose and Post-dose of QRS Axis
Week8; n=33, 47
|
1.2 Degrees
Standard Deviation 10.01
|
-0.2 Degrees
Standard Deviation 9.30
|
|
Change Between Pre-dose and Post-dose of QRS Axis
Week12; n=24, 39
|
-1.6 Degrees
Standard Deviation 6.44
|
2.8 Degrees
Standard Deviation 14.25
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4 and 12Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Using a Holter monitor, maximum, minimum and average changes in heart rate was recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Mean Heart Rate: Week0; n=81, 80
|
-1.1 Beats per minute
Standard Deviation 6.56
|
-2.0 Beats per minute
Standard Deviation 6.00
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Mean Heart Rate: Week4; n=49, 58
|
76.8 Beats per minute
Standard Deviation 10.60
|
80.0 Beats per minute
Standard Deviation 10.80
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Mean Heart Rate: Week12; n=24, 37
|
78.8 Beats per minute
Standard Deviation 11.12
|
79.9 Beats per minute
Standard Deviation 10.08
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Maximum Heart Rate: Week0; n=81, 80
|
-0.3 Beats per minute
Standard Deviation 13.13
|
-5.0 Beats per minute
Standard Deviation 14.55
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Maximum Heart Rate: Week4; n=49, 58
|
128.3 Beats per minute
Standard Deviation 13.03
|
130.3 Beats per minute
Standard Deviation 16.41
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Maximum Heart Rate: Week12; n=24, 37
|
128.5 Beats per minute
Standard Deviation 15.21
|
132.1 Beats per minute
Standard Deviation 15.80
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Minimum Heart Rate: Week0; n=81, 80
|
-0.8 Beats per minute
Standard Deviation 5.08
|
-0.8 Beats per minute
Standard Deviation 4.55
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Minimum Heart Rate: Week4; n=49, 58
|
50.6 Beats per minute
Standard Deviation 7.49
|
53.8 Beats per minute
Standard Deviation 8.15
|
|
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Minimum Heart Rate: Week12; n=24, 37
|
53.6 Beats per minute
Standard Deviation 7.49
|
53.4 Beats per minute
Standard Deviation 9.09
|
SECONDARY outcome
Timeframe: Baseline and Weeks 0, 4 and 12Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Using a Holter monitor, supraventricular couplets, supraventricular ectopics, supraventricular runs, supraventricular singles, ventricular couplets, ventricular ectopics, ventricular runs, ventricular singles were recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=80 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular singles: Week0; n=81, 80
|
9.0 Events per hour
Standard Deviation 349.81
|
-13.1 Events per hour
Standard Deviation 120.73
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular singles: Week4; n=49, 58
|
-25.3 Events per hour
Standard Deviation 425.20
|
-3.1 Events per hour
Standard Deviation 138.30
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular runs: Week4; n=49, 58
|
-0.1 Events per hour
Standard Deviation 2.37
|
-0.6 Events per hour
Standard Deviation 3.01
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular runs: Week12; n=24, 37
|
-1.1 Events per hour
Standard Deviation 6.30
|
-0.4 Events per hour
Standard Deviation 1.83
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular singles: Week12; n=24, 37
|
45.5 Events per hour
Standard Deviation 263.03
|
8.4 Events per hour
Standard Deviation 89.64
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular couplets: Week0; n=81, 80
|
0.7 Events per hour
Standard Deviation 3.80
|
-0.1 Events per hour
Standard Deviation 1.59
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular couplets: Week4; n=49, 58
|
0.2 Events per hour
Standard Deviation 0.80
|
0.1 Events per hour
Standard Deviation 0.65
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular couplets: Week12; n=24, 37
|
0.0 Events per hour
Standard Deviation 0.00
|
0.3 Events per hour
Standard Deviation 1.43
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular ectopics: Week0; n=81, 80
|
44.6 Events per hour
Standard Deviation 265.28
|
-12.2 Events per hour
Standard Deviation 141.39
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular ectopics: Week4; n=49, 58
|
-10.7 Events per hour
Standard Deviation 105.24
|
6.4 Events per hour
Standard Deviation 54.80
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular ectopics: Week12; n=24, 37
|
-5.3 Events per hour
Standard Deviation 52.78
|
176.0 Events per hour
Standard Deviation 926.75
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular runs: Week0; n=81, 80
|
0.0 Events per hour
Standard Deviation 0.25
|
0.0 Events per hour
Standard Deviation 0.19
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular runs: Week4; n=49, 58
|
0.0 Events per hour
Standard Deviation 0.29
|
0.0 Events per hour
Standard Deviation 0.00
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular runs: Week12; n=24, 37
|
0.0 Events per hour
Standard Deviation 0.29
|
0.0 Events per hour
Standard Deviation 0.00
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular singles: Week0; n=81, 80
|
44.0 Events per hour
Standard Deviation 228.09
|
-12.2 Events per hour
Standard Deviation 139.28
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular singles: Week4; n=49, 58
|
-10.4 Events per hour
Standard Deviation 104.12
|
6.3 Events per hour
Standard Deviation 53.79
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
ventricular singles: Week12; n=24, 37
|
-5.4 Events per hour
Standard Deviation 53.23
|
174.5 Events per hour
Standard Deviation 921.42
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular couplets: Week0; n=81, 80
|
-2.0 Events per hour
Standard Deviation 21.68
|
16.5 Events per hour
Standard Deviation 144.04
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular couplets: Week4; n=49, 58
|
-1.9 Events per hour
Standard Deviation 14.11
|
-2.2 Events per hour
Standard Deviation 9.86
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular couplets: Week12; n=24, 37
|
-3.9 Events per hour
Standard Deviation 35.82
|
-0.5 Events per hour
Standard Deviation 3.48
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular ectopics: Week0; n=81, 80
|
2.6 Events per hour
Standard Deviation 369.71
|
6.8 Events per hour
Standard Deviation 188.46
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular ectopics: Week4; n=49, 58
|
-30.9 Events per hour
Standard Deviation 445.93
|
-7.3 Events per hour
Standard Deviation 148.20
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular ectopics: Week12; n=24, 37
|
34.9 Events per hour
Standard Deviation 300.07
|
9.4 Events per hour
Standard Deviation 94.82
|
|
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
supraventricular runs: Week0; n=81, 80
|
-0.5 Events per hour
Standard Deviation 3.62
|
0.2 Events per hour
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of clinical chemistry parameters including AST, ALT, ALP, GGT and CK at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
AST:Week 16, n=24, 39
|
-1.4 International units per liter
Standard Deviation 6.01
|
-3.3 International units per liter
Standard Deviation 6.70
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
AST:Week 28, n=74, 74
|
-2.3 International units per liter
Standard Deviation 6.96
|
-1.7 International units per liter
Standard Deviation 8.64
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
CK: Week 2, n=72, 74
|
-12.5 International units per liter
Standard Deviation 92.00
|
-18.8 International units per liter
Standard Deviation 207.72
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
CK:Week 4, n=47,59
|
-30.3 International units per liter
Standard Deviation 68.86
|
-45.1 International units per liter
Standard Deviation 231.07
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
CK:Week 8, n=34,47
|
-26.6 International units per liter
Standard Deviation 57.01
|
-32.9 International units per liter
Standard Deviation 242.98
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
CK:Week 12, n=24, 36
|
-5.0 International units per liter
Standard Deviation 73.56
|
-54.5 International units per liter
Standard Deviation 282.17
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
CK:Week 16, n=24, 39
|
-20.8 International units per liter
Standard Deviation 81.02
|
-46.8 International units per liter
Standard Deviation 272.08
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
CK:Week 28, n=74, 74
|
-8.5 International units per liter
Standard Deviation 131.56
|
-30.7 International units per liter
Standard Deviation 199.41
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
GGT: Week 2, n=72, 74
|
-3.2 International units per liter
Standard Deviation 9.61
|
-1.2 International units per liter
Standard Deviation 12.16
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
GGT:Week 4, n=47,59
|
-3.9 International units per liter
Standard Deviation 14.00
|
-2.5 International units per liter
Standard Deviation 21.35
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
GGT:Week 8, n=34,47
|
-3.5 International units per liter
Standard Deviation 13.50
|
-2.8 International units per liter
Standard Deviation 15.61
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
GGT:Week 12, 24, 36
|
-0.3 International units per liter
Standard Deviation 5.87
|
-5.4 International units per liter
Standard Deviation 19.48
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
GGT:Week 16, n=24, 39
|
-1.1 International units per liter
Standard Deviation 4.41
|
-3.9 International units per liter
Standard Deviation 14.64
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
GGT:Week 28, n=74, 73
|
-3.2 International units per liter
Standard Deviation 13.80
|
-0.7 International units per liter
Standard Deviation 16.06
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
AST:Week 8, n=34,47
|
-1.6 International units per liter
Standard Deviation 6.58
|
-2.7 International units per liter
Standard Deviation 6.36
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALP:Week 16; n=24, 39
|
1.0 International units per liter
Standard Deviation 9.33
|
-2.3 International units per liter
Standard Deviation 9.75
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALP:Week 28; n=74, 74
|
-0.4 International units per liter
Standard Deviation 12.33
|
-1.2 International units per liter
Standard Deviation 13.25
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
AST:Week 12, n=24, 36
|
-1.8 International units per liter
Standard Deviation 4.91
|
-4.1 International units per liter
Standard Deviation 6.59
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
AST: Week 2; n=72, 74
|
-0.8 International units per liter
Standard Deviation 9.30
|
-1.5 International units per liter
Standard Deviation 6.59
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
AST:Week 4; n=47,59
|
-1.0 International units per liter
Standard Deviation 6.02
|
-2.5 International units per liter
Standard Deviation 6.75
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALT: Week 2; n=72, 74
|
-0.9 International units per liter
Standard Deviation 8.88
|
-0.2 International units per liter
Standard Deviation 7.07
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALT:Week 4; n=47,59
|
-0.5 International units per liter
Standard Deviation 9.50
|
-2.6 International units per liter
Standard Deviation 7.24
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALT: Week 8; n=34,47
|
-0.1 International units per liter
Standard Deviation 6.93
|
-2.4 International units per liter
Standard Deviation 7.30
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALT: Week 12; n=24, 36
|
-1.6 International units per liter
Standard Deviation 6.86
|
-2.4 International units per liter
Standard Deviation 7.77
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALT: Week 16; n=24, 39
|
-1.2 International units per liter
Standard Deviation 7.97
|
-2.6 International units per liter
Standard Deviation 6.54
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALT: Week 28; n=74, 74
|
-1.1 International units per liter
Standard Deviation 9.57
|
-0.9 International units per liter
Standard Deviation 10.51
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALP: Week 2; n=72, 74
|
-1.9 International units per liter
Standard Deviation 8.32
|
-0.8 International units per liter
Standard Deviation 8.96
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALP:Week 4; n=47, 59
|
-0.8 International units per liter
Standard Deviation 13.18
|
-1.0 International units per liter
Standard Deviation 8.17
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALP:Week 8; n=34, 47
|
0.9 International units per liter
Standard Deviation 7.37
|
-2.3 International units per liter
Standard Deviation 8.64
|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
ALP:Week 12; n =24, 36
|
2.4 International units per liter
Standard Deviation 8.79
|
-3.0 International units per liter
Standard Deviation 14.01
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points to assess clinical chemistry parameters including glucose, potassium, sodium, calcium, Phosphate, chloride, urea and CO2 levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Phosphate:Week 12; n=24, 36
|
0.025 Millimoles per liter
Standard Deviation 0.1133
|
-0.013 Millimoles per liter
Standard Deviation 0.1495
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Phosphate:Week 28; n=74, 73
|
-0.013 Millimoles per liter
Standard Deviation 0.1854
|
-0.018 Millimoles per liter
Standard Deviation 0.1743
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Chloride: Week 2; n=72, 74
|
0.3 Millimoles per liter
Standard Deviation 2.47
|
0.1 Millimoles per liter
Standard Deviation 2.22
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Glucose: Week 2; n=72, 74
|
0.13 Millimoles per liter
Standard Deviation 0.996
|
0.05 Millimoles per liter
Standard Deviation 1.273
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Glucose:Week 4; n=47,59
|
0.18 Millimoles per liter
Standard Deviation 0.784
|
0.19 Millimoles per liter
Standard Deviation 1.156
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Glucose:Week 8; n=34,47
|
0.26 Millimoles per liter
Standard Deviation 1.008
|
0.00 Millimoles per liter
Standard Deviation 1.400
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Glucose:Week 12; n=24, 36
|
-0.04 Millimoles per liter
Standard Deviation 0.796
|
0.20 Millimoles per liter
Standard Deviation 1.516
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Glucose:Week 16; n=24, 39
|
-0.10 Millimoles per liter
Standard Deviation 1.057
|
0.12 Millimoles per liter
Standard Deviation 0.984
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Glucose:Week 28; n=74, 73
|
0.30 Millimoles per liter
Standard Deviation 1.245
|
0.04 Millimoles per liter
Standard Deviation 1.780
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Potassium: Week 2; n=72, 74
|
0.14 Millimoles per liter
Standard Deviation 0.366
|
0.13 Millimoles per liter
Standard Deviation 0.596
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Potassium:Week 4; n=47,59
|
0.04 Millimoles per liter
Standard Deviation 0.361
|
0.05 Millimoles per liter
Standard Deviation 0.402
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Potassium:Week 8; n=34,47
|
-0.01 Millimoles per liter
Standard Deviation 0.352
|
-0.04 Millimoles per liter
Standard Deviation 0.397
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Potassium:Week 12; n=24, 36
|
0.02 Millimoles per liter
Standard Deviation 0.363
|
0.00 Millimoles per liter
Standard Deviation 0.439
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Potassium:Week 16; n=24, 39
|
-0.09 Millimoles per liter
Standard Deviation 0.403
|
0.00 Millimoles per liter
Standard Deviation 0.439
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Potassium:Week 28; n=74, 73
|
0.01 Millimoles per liter
Standard Deviation 0.407
|
0.01 Millimoles per liter
Standard Deviation 0.416
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Sodium: Week 2; n=72, 74
|
0.3 Millimoles per liter
Standard Deviation 2.19
|
-0.1 Millimoles per liter
Standard Deviation 2.31
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Sodium:Week 4; n=47,59
|
0.0 Millimoles per liter
Standard Deviation 1.65
|
-0.9 Millimoles per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Sodium:Week 8; n=34,47
|
-0.1 Millimoles per liter
Standard Deviation 1.41
|
-0.6 Millimoles per liter
Standard Deviation 1.51
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Sodium:Week 12; n=24, 36
|
-0.3 Millimoles per liter
Standard Deviation 2.17
|
-1.1 Millimoles per liter
Standard Deviation 1.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Sodium:Week 16; n=24, 39
|
-0.2 Millimoles per liter
Standard Deviation 2.14
|
-0.3 Millimoles per liter
Standard Deviation 2.01
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Sodium:Week 28; n=74, 73
|
0.5 Millimoles per liter
Standard Deviation 2.55
|
-0.2 Millimoles per liter
Standard Deviation 2.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Calcium: Week 2; n=72, 74
|
-0.006 Millimoles per liter
Standard Deviation 0.0691
|
0.001 Millimoles per liter
Standard Deviation 0.0925
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Calcium:Week 4; n=47,59
|
-0.013 Millimoles per liter
Standard Deviation 0.0873
|
-0.005 Millimoles per liter
Standard Deviation 0.0743
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Calcium:Week 8; n=34,47
|
-0.005 Millimoles per liter
Standard Deviation 0.0648
|
-0.003 Millimoles per liter
Standard Deviation 0.0997
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Calcium:Week 12; n=24, 36
|
0.018 Millimoles per liter
Standard Deviation 0.0962
|
-0.004 Millimoles per liter
Standard Deviation 0.0949
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Calcium:Week 16; n=24, 39
|
0.014 Millimoles per liter
Standard Deviation 0.0950
|
0.017 Millimoles per liter
Standard Deviation 0.0963
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Calcium:Week 28; n=74, 73
|
0.001 Millimoles per liter
Standard Deviation 0.0776
|
0.001 Millimoles per liter
Standard Deviation 0.0994
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Phosphate: Week 2; n=72, 74
|
0.031 Millimoles per liter
Standard Deviation 0.1467
|
-0.023 Millimoles per liter
Standard Deviation 0.1502
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Phosphate:Week 4; n=47,59
|
0.003 Millimoles per liter
Standard Deviation 0.1312
|
-0.011 Millimoles per liter
Standard Deviation 0.1362
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Phosphate:Week 8; n=34,47
|
0.006 Millimoles per liter
Standard Deviation 0.1678
|
-0.049 Millimoles per liter
Standard Deviation 0.1420
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Phosphate:Week 16; n=24, 39
|
-0.006 Millimoles per liter
Standard Deviation 0.1370
|
-0.019 Millimoles per liter
Standard Deviation 0.1503
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Chloride:Week 4; n=47,59
|
0.0 Millimoles per liter
Standard Deviation 2.04
|
-0.3 Millimoles per liter
Standard Deviation 2.18
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Chloride:Week 8; n=34,47
|
-0.2 Millimoles per liter
Standard Deviation 1.97
|
0.0 Millimoles per liter
Standard Deviation 2.03
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Chloride:Week 12; n=24, 36
|
-0.1 Millimoles per liter
Standard Deviation 2.61
|
-0.3 Millimoles per liter
Standard Deviation 2.13
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Chloride:Week 16; n=24, 39
|
-0.4 Millimoles per liter
Standard Deviation 2.95
|
-0.2 Millimoles per liter
Standard Deviation 2.61
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Chloride:Week 28; n=74, 73
|
0.6 Millimoles per liter
Standard Deviation 2.65
|
0.7 Millimoles per liter
Standard Deviation 2.24
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
CO2: Week 2; n=72, 74
|
-0.4 Millimoles per liter
Standard Deviation 2.71
|
0.4 Millimoles per liter
Standard Deviation 2.10
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
CO2:Week 4; n=47,59
|
-0.4 Millimoles per liter
Standard Deviation 2.26
|
0.3 Millimoles per liter
Standard Deviation 2.82
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
CO2:Week 8; n=34,46
|
-0.3 Millimoles per liter
Standard Deviation 1.95
|
-0.3 Millimoles per liter
Standard Deviation 1.84
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
CO2:Week 12; n=24, 36
|
-0.5 Millimoles per liter
Standard Deviation 2.60
|
-0.1 Millimoles per liter
Standard Deviation 2.10
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
CO2:Week 16; n=24, 39
|
-0.5 Millimoles per liter
Standard Deviation 2.34
|
0.1 Millimoles per liter
Standard Deviation 2.28
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
CO2:Week 28; n=74, 73
|
-0.1 Millimoles per liter
Standard Deviation 2.28
|
0.3 Millimoles per liter
Standard Deviation 2.15
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Urea: Week 2; n=72, 74
|
0.08 Millimoles per liter
Standard Deviation 1.311
|
-0.14 Millimoles per liter
Standard Deviation 1.108
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Urea:Week 4; n=47,59
|
0.16 Millimoles per liter
Standard Deviation 1.344
|
-0.14 Millimoles per liter
Standard Deviation 1.102
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Urea:Week 8; n=34,47
|
-0.04 Millimoles per liter
Standard Deviation 1.264
|
0.27 Millimoles per liter
Standard Deviation 1.151
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Urea:Week 12; n=24, 36
|
0.58 Millimoles per liter
Standard Deviation 1.537
|
-0.06 Millimoles per liter
Standard Deviation 1.346
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Urea:Week 16; n=24, 39
|
0.48 Millimoles per liter
Standard Deviation 1.379
|
0.03 Millimoles per liter
Standard Deviation 1.287
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Urea:Week 28; n=74, 73
|
0.08 Millimoles per liter
Standard Deviation 1.089
|
0.16 Millimoles per liter
Standard Deviation 1.121
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of clinical chemistry parameters including total bilirubin, creatinine and direct bilirubin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine:Week 28; n=74, 73
|
4.32 Micromoles per liter
Standard Deviation 6.810
|
2.9 Micromoles per liter
Standard Deviation 6.356
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine: Week 2; n=72, 74
|
2.35 Micromoles per liter
Standard Deviation 6.911
|
1.71 Micromoles per liter
Standard Deviation 8.321
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine:Week 4; n=47, 59
|
2.35 Micromoles per liter
Standard Deviation 8.319
|
0.72 Micromoles per liter
Standard Deviation 6.610
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine:Week 8; n=34, 47
|
1.18 Micromoles per liter
Standard Deviation 7.677
|
1.76 Micromoles per liter
Standard Deviation 6.072
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine:Week 12; n=24, 36
|
2.42 Micromoles per liter
Standard Deviation 6.521
|
0.02 Micromoles per liter
Standard Deviation 5.866
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine:Week 16; n=24, 39
|
2.50 Micromoles per liter
Standard Deviation 8.685
|
0.91 Micromoles per liter
Standard Deviation 6.105
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Total Bilirubin : Week 2; n=72, 74
|
-0.1 Micromoles per liter
Standard Deviation 3.22
|
0.1 Micromoles per liter
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Total Bilirubin :Week 4; n=47, 59
|
-0.3 Micromoles per liter
Standard Deviation 3.24
|
-0.4 Micromoles per liter
Standard Deviation 2.98
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Total Bilirubin :Week 8; n=34, 47
|
-0.1 Micromoles per liter
Standard Deviation 2.46
|
-0.2 Micromoles per liter
Standard Deviation 4.04
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Total Bilirubin :Week 12; n=24, 36
|
-0.6 Micromoles per liter
Standard Deviation 2.32
|
0.1 Micromoles per liter
Standard Deviation 4.56
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Total Bilirubin :Week 16; n=24, 39
|
0.0 Micromoles per liter
Standard Deviation 2.83
|
-0.3 Micromoles per liter
Standard Deviation 3.39
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Total Bilirubin :Week 28; n=74, 74
|
0.1 Micromoles per liter
Standard Deviation 2.77
|
-0.5 Micromoles per liter
Standard Deviation 3.94
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin : Week 2; n=72, 74
|
-0.1 Micromoles per liter
Standard Deviation 1.18
|
0.0 Micromoles per liter
Standard Deviation 1.02
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin :Week 4; n=47,59
|
-0.1 Micromoles per liter
Standard Deviation 0.97
|
0.1 Micromoles per liter
Standard Deviation 1.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin :Week 8; n=34, 47
|
-0.1 Micromoles per liter
Standard Deviation 1.04
|
0.2 Micromoles per liter
Standard Deviation 1.17
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin :Week 12; n=24, 36
|
-0.4 Micromoles per liter
Standard Deviation 1.18
|
0.2 Micromoles per liter
Standard Deviation 1.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin :Week 16; n=24, 39
|
0.1 Micromoles per liter
Standard Deviation 1.50
|
0.1 Micromoles per liter
Standard Deviation 1.07
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin :Week 28; n=74, 74
|
0.1 Micromoles per liter
Standard Deviation 1.17
|
0.1 Micromoles per liter
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points to assess clinical chemistry parameters including total protein and albumin levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Total Protein: Week 2, n=72, 74
|
-0.5 Grams per liter
Standard Deviation 3.49
|
0.4 Grams per liter
Standard Deviation 3.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Total Protein:Week 4, n=47,59
|
-0.4 Grams per liter
Standard Deviation 3.44
|
-0.4 Grams per liter
Standard Deviation 3.76
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Total Protein:Week 8, n=34,47
|
0.1 Grams per liter
Standard Deviation 3.20
|
0.8 Grams per liter
Standard Deviation 3.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Total Protein:Week 12, n=24, 36
|
0.2 Grams per liter
Standard Deviation 4.05
|
-0.6 Grams per liter
Standard Deviation 4.79
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Total Protein:Week 16, n=24, 39
|
0.5 Grams per liter
Standard Deviation 4.33
|
0.4 Grams per liter
Standard Deviation 3.34
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Total Protein:Week 28, n=74, 73
|
-0.8 Grams per liter
Standard Deviation 4.04
|
-0.2 Grams per liter
Standard Deviation 4.27
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Albumin: Week 2, n=72, 74
|
-0.5 Grams per liter
Standard Deviation 2.38
|
-0.4 Grams per liter
Standard Deviation 2.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Albumin:Week 4, n=47,59
|
-0.5 Grams per liter
Standard Deviation 2.29
|
-0.8 Grams per liter
Standard Deviation 2.62
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Albumin:Week 8, n=34,47
|
-0.4 Grams per liter
Standard Deviation 2.36
|
0.0 Grams per liter
Standard Deviation 2.38
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Albumin:Week 12, n=24, 36
|
-0.3 Grams per liter
Standard Deviation 2.40
|
-0.9 Grams per liter
Standard Deviation 2.69
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Albumin:Week 16, n=24, 39
|
-0.1 Grams per liter
Standard Deviation 2.82
|
-0.4 Grams per liter
Standard Deviation 2.25
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Albumin:Week 28, n=74, 73
|
-0.6 Grams per liter
Standard Deviation 2.70
|
-0.6 Grams per liter
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points to assess hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, leutrophils, monocytes, and platelets . Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 16; n=23, 39
|
-0.41 10^9 cells per liter
Standard Deviation 1.296
|
0.18 10^9 cells per liter
Standard Deviation 1.511
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 28; n=65, 60
|
0.041 10^9 cells per liter
Standard Deviation 0.1431
|
0.066 10^9 cells per liter
Standard Deviation 0.1218
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 12; n=24, 39
|
3.6 10^9 cells per liter
Standard Deviation 46.24
|
6.6 10^9 cells per liter
Standard Deviation 27.79
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 14; n=24, 39
|
-6.4 10^9 cells per liter
Standard Deviation 45.37
|
5.5 10^9 cells per liter
Standard Deviation 32.66
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 16; n=24, 38
|
-0.5 10^9 cells per liter
Standard Deviation 37.57
|
6.3 10^9 cells per liter
Standard Deviation 40.13
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 28; n=64, 62
|
-3.5 10^9 cells per liter
Standard Deviation 35.52
|
3.0 10^9 cells per liter
Standard Deviation 52.16
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 28; n= 65, 60
|
0.006 10^9 cells per liter
Standard Deviation 0.0364
|
0.007 10^9 cells per liter
Standard Deviation 0.0353
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil: Week 1; n=77, 74
|
-0.031 10^9 cells per liter
Standard Deviation 0.2868
|
-0.038 10^9 cells per liter
Standard Deviation 0.1424
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil: Week 1; n=77, 74
|
0.001 10^9 cells per liter
Standard Deviation 0.0361
|
-0.001 10^9 cells per liter
Standard Deviation 0.0396
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 2; n= 68, 72
|
0.003 10^9 cells per liter
Standard Deviation 0.0350
|
0.005 10^9 cells per liter
Standard Deviation 0.0346
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 4; n=48, 57
|
0.005 10^9 cells per liter
Standard Deviation 0.0341
|
0.004 10^9 cells per liter
Standard Deviation 0.0409
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 6; n=43, 54
|
0.006 10^9 cells per liter
Standard Deviation 0.0420
|
0.007 10^9 cells per liter
Standard Deviation 0.0363
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 8; n=33, 46
|
0.002 10^9 cells per liter
Standard Deviation 0.0449
|
-0.001 10^9 cells per liter
Standard Deviation 0.0366
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 10; n= 32, 44
|
0.004 10^9 cells per liter
Standard Deviation 0.0345
|
0.010 10^9 cells per liter
Standard Deviation 0.0367
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 12; n=24, 39
|
0.010 10^9 cells per liter
Standard Deviation 0.0262
|
0.010 10^9 cells per liter
Standard Deviation 0.0312
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 14; n=23, 39
|
-0.003 10^9 cells per liter
Standard Deviation 0.0255
|
0.012 10^9 cells per liter
Standard Deviation 0.0338
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Basophil:Week 16; n=23, 39
|
-0.005 10^9 cells per liter
Standard Deviation 0.0316
|
0.006 10^9 cells per liter
Standard Deviation 0.0409
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 2; n=68, 72
|
-0.050 10^9 cells per liter
Standard Deviation 0.2105
|
-0.051 10^9 cells per liter
Standard Deviation 0.1892
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 4; n=48, 57
|
-0.048 10^9 cells per liter
Standard Deviation 0.2585
|
-0.119 10^9 cells per liter
Standard Deviation 0.1522
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 6; n =43, 54
|
-0.023 10^9 cells per liter
Standard Deviation 0.2714
|
-0.119 10^9 cells per liter
Standard Deviation 0.1950
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 8; n= 33, 46
|
-0.014 10^9 cells per liter
Standard Deviation 0.2069
|
-0.096 10^9 cells per liter
Standard Deviation 0.2134
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 10 n=32, 44
|
0.000 10^9 cells per liter
Standard Deviation 0.2387
|
-0.041 10^9 cells per liter
Standard Deviation 0.2371
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 12; n=24, 39
|
-0.039 10^9 cells per liter
Standard Deviation 0.2621
|
-0.066 10^9 cells per liter
Standard Deviation 0.1939
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 14; n=23, 39
|
0.018 10^9 cells per liter
Standard Deviation 0.1888
|
-0.034 10^9 cells per liter
Standard Deviation 0.2481
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 16; n=23, 39
|
-0.018 10^9 cells per liter
Standard Deviation 0.2456
|
-0.093 10^9 cells per liter
Standard Deviation 0.2350
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Eosinophil:Week 28; n= 65, 60
|
0.010 10^9 cells per liter
Standard Deviation 0.2077
|
-0.087 10^9 cells per liter
Standard Deviation 0.1865
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes: Week 1; n=78, 74
|
0.14 10^9 cells per liter
Standard Deviation 1.614
|
0.07 10^9 cells per liter
Standard Deviation 1.314
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 2; n= 68, 73
|
0.01 10^9 cells per liter
Standard Deviation 1.202
|
0.09 10^9 cells per liter
Standard Deviation 1.117
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 4; n =48, 57
|
0.24 10^9 cells per liter
Standard Deviation 1.406
|
0.19 10^9 cells per liter
Standard Deviation 1.401
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 6; n=43, 54
|
0.37 10^9 cells per liter
Standard Deviation 1.346
|
-0.12 10^9 cells per liter
Standard Deviation 1.040
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 8; n=33, 47
|
0.08 10^9 cells per liter
Standard Deviation 1.045
|
0.14 10^9 cells per liter
Standard Deviation 2.248
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 10; n=33, 45
|
0.01 10^9 cells per liter
Standard Deviation 1.102
|
0.03 10^9 cells per liter
Standard Deviation 1.259
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 12; n=24, 39
|
0.13 10^9 cells per liter
Standard Deviation 1.257
|
0.18 10^9 cells per liter
Standard Deviation 1.038
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 14; n= 23, 39
|
-0.17 10^9 cells per liter
Standard Deviation 1.324
|
0.26 10^9 cells per liter
Standard Deviation 1.220
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Leukocytes:Week 28; n=65, 63
|
-0.08 10^9 cells per liter
Standard Deviation 1.545
|
0.09 10^9 cells per liter
Standard Deviation 1.392
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes: Week 1; n=77, 74
|
0.036 10^9 cells per liter
Standard Deviation 0.4248
|
-0.008 10^9 cells per liter
Standard Deviation 0.3292
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 2; n=68, 72
|
0.006 10^9 cells per liter
Standard Deviation 0.3437
|
0.039 10^9 cells per liter
Standard Deviation 0.4112
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 4; n=48, 57
|
0.043 10^9 cells per liter
Standard Deviation 0.4048
|
0.061 10^9 cells per liter
Standard Deviation 0.2995
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 6; n=43, 54
|
0.140 10^9 cells per liter
Standard Deviation 0.4994
|
0.086 10^9 cells per liter
Standard Deviation 0.3986
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 8; n=33, 46
|
0.132 10^9 cells per liter
Standard Deviation 0.3257
|
0.033 10^9 cells per liter
Standard Deviation 0.3477
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 10; n=32, 44
|
0.103 10^9 cells per liter
Standard Deviation 0.4275
|
0.105 10^9 cells per liter
Standard Deviation 0.4105
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 12; n=24, 39
|
0.098 10^9 cells per liter
Standard Deviation 0.3657
|
0.044 10^9 cells per liter
Standard Deviation 0.3546
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 14; n=23, 39
|
0.009 10^9 cells per liter
Standard Deviation 0.3590
|
0.119 10^9 cells per liter
Standard Deviation 0.4346
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 16; n=23, 39
|
0.02 10^9 cells per liter
Standard Deviation 0.3825
|
0.075 10^9 cells per liter
Standard Deviation 0.4397
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Lymphocytes:Week 28; n=65, 60
|
0.065 10^9 cells per liter
Standard Deviation 0.4601
|
0.162 10^9 cells per liter
Standard Deviation 0.4794
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils: Week 1; n=77, 74
|
0.079 10^9 cells per liter
Standard Deviation 1.4665
|
0.092 10^9 cells per liter
Standard Deviation 1.1019
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 2; n=68, 72
|
0.023 10^9 cells per liter
Standard Deviation 1.0414
|
0.035 10^9 cells per liter
Standard Deviation 0.8299
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 4; n=48, 57
|
0.187 10^9 cells per liter
Standard Deviation 1.2738
|
0.217 10^9 cells per liter
Standard Deviation 1.2788
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 6; n=43, 54
|
0.203 10^9 cells per liter
Standard Deviation 1.3952
|
-0.126 10^9 cells per liter
Standard Deviation 0.8524
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 8; n=33, 46
|
-0.080 10^9 cells per liter
Standard Deviation 0.9654
|
0.331 10^9 cells per liter
Standard Deviation 2.0776
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 10; n=32, 44
|
-0.192 10^9 cells per liter
Standard Deviation 0.9739
|
0.041 10^9 cells per liter
Standard Deviation 0.9173
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 12; n=24, 39
|
-0.013 10^9 cells per liter
Standard Deviation 1.2306
|
0.158 10^9 cells per liter
Standard Deviation 0.8630
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 14; n=23, 39
|
-0.263 10^9 cells per liter
Standard Deviation 1.3117
|
0.073 10^9 cells per liter
Standard Deviation 0.9305
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 16; n=23, 39
|
-0.448 10^9 cells per liter
Standard Deviation 1.1201
|
0.142 10^9 cells per liter
Standard Deviation 1.2595
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Neutrophils:Week 28; n=65, 60
|
-0.201 10^9 cells per liter
Standard Deviation 1.5148
|
-0.045 10^9 cells per liter
Standard Deviation 1.1145
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes: Week 1; n=77, 74
|
0.026 10^9 cells per liter
Standard Deviation 0.1595
|
0.015 10^9 cells per liter
Standard Deviation 0.1209
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 2; n=68, 72
|
0.020 10^9 cells per liter
Standard Deviation 0.1226
|
0.022 10^9 cells per liter
Standard Deviation 0.0965
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 4; n=48, 57
|
0.051 10^9 cells per liter
Standard Deviation 0.1869
|
0.027 10^9 cells per liter
Standard Deviation 0.1014
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 6; n=43, 54
|
0.050 10^9 cells per liter
Standard Deviation 0.1353
|
0.038 10^9 cells per liter
Standard Deviation 0.1083
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 8; n=33, 46
|
0.045 10^9 cells per liter
Standard Deviation 0.1152
|
0.023 10^9 cells per liter
Standard Deviation 0.1038
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 10; n=32, 44
|
0.090 10^9 cells per liter
Standard Deviation 0.1463
|
0.038 10^9 cells per liter
Standard Deviation 0.100
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 12; n=24, 39
|
0.073 10^9 cells per liter
Standard Deviation 0.1362
|
0.025 10^9 cells per liter
Standard Deviation 0.0948
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 14; n=23, 39
|
0.059 10^9 cells per liter
Standard Deviation 0.1301
|
0.082 10^9 cells per liter
Standard Deviation 0.103
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Monocytes:Week 16; n=23, 39
|
0.040 10^9 cells per liter
Standard Deviation 0.1087
|
0.053 10^9 cells per liter
Standard Deviation 0.1075
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets: Week 1; n=78, 74
|
1.5 10^9 cells per liter
Standard Deviation 31.89
|
8.7 10^9 cells per liter
Standard Deviation 44.52
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 2; n=71, 74
|
7.6 10^9 cells per liter
Standard Deviation 35.72
|
9.8 10^9 cells per liter
Standard Deviation 44.42
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 4; n=49, 57
|
4.0 10^9 cells per liter
Standard Deviation 27.64
|
5.3 10^9 cells per liter
Standard Deviation 33.05
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 6; n=44, 56
|
18.2 10^9 cells per liter
Standard Deviation 46.02
|
3.9 10^9 cells per liter
Standard Deviation 35.62
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 8; n=34, 47
|
8.6 10^9 cells per liter
Standard Deviation 38.79
|
-1.1 10^9 cells per liter
Standard Deviation 30.31
|
|
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Platelets:Week 10; n=34, 45
|
10.9 10^9 cells per liter
Standard Deviation 45.93
|
4.7 10^9 cells per liter
Standard Deviation 30.88
|
SECONDARY outcome
Timeframe: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed . Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of erythrocyte mean corpuscular volume at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 14: n=24, 39
|
-0.7 Femtoliters
Standard Deviation 1.63
|
-1.5 Femtoliters
Standard Deviation 2.46
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 1: n=78,74
|
0.3 Femtoliters
Standard Deviation 1.59
|
-0.1 Femtoliters
Standard Deviation 1.46
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 2: n=71, 74
|
0.2 Femtoliters
Standard Deviation 1.44
|
-0.2 Femtoliters
Standard Deviation 1.62
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 4: n=49, 57
|
-0.4 Femtoliters
Standard Deviation 1.62
|
-0.6 Femtoliters
Standard Deviation 1.98
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 6: n=44, 56
|
-0.3 Femtoliters
Standard Deviation 1.29
|
-0.4 Femtoliters
Standard Deviation 2.33
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 8: n=34, 47
|
-0.9 Femtoliters
Standard Deviation 1.37
|
-0.6 Femtoliters
Standard Deviation 2.13
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 10: n=34, 45
|
-1.1 Femtoliters
Standard Deviation 1.82
|
-0.9 Femtoliters
Standard Deviation 2.52
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 12: n=24, 39
|
-0.7 Femtoliters
Standard Deviation 1.46
|
-1.3 Femtoliters
Standard Deviation 2.61
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 16: n=24, 39
|
-0.6 Femtoliters
Standard Deviation 1.58
|
-2.3 Femtoliters
Standard Deviation 2.67
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Week 28: n=65, 63
|
-1.6 Femtoliters
Standard Deviation 2.76
|
-2.9 Femtoliters
Standard Deviation 5.20
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of erythrocytes at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 2: n=71, 74
|
0.01 10^12 cells per liter
Standard Deviation 0.232
|
0.01 10^12 cells per liter
Standard Deviation 0.200
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 8: n=34, 47
|
0.02 10^12 cells per liter
Standard Deviation 0.210
|
0.02 10^12 cells per liter
Standard Deviation 0.234
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 10: n=34, 45
|
0.00 10^12 cells per liter
Standard Deviation 0.228
|
-0.02 10^12 cells per liter
Standard Deviation 0.201
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 12: n=24, 39
|
0.06 10^12 cells per liter
Standard Deviation 0.226
|
-0.03 10^12 cells per liter
Standard Deviation 0.297
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 16: n=24, 39
|
0.00 10^12 cells per liter
Standard Deviation 0.184
|
0.03 10^12 cells per liter
Standard Deviation 0.236
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 28: n=65, 63
|
0.09 10^12 cells per liter
Standard Deviation 0.260
|
0.09 10^12 cells per liter
Standard Deviation 0.381
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 1: n=78,74
|
-0.01 10^12 cells per liter
Standard Deviation 0.220
|
-0.03 10^12 cells per liter
Standard Deviation 0.232
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 4: n=49, 57
|
0.05 10^12 cells per liter
Standard Deviation 0.298
|
-0.01 10^12 cells per liter
Standard Deviation 0.169
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 6: n=44, 56
|
0.05 10^12 cells per liter
Standard Deviation 0.181
|
-0.04 10^12 cells per liter
Standard Deviation 0.170
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 14: n=24, 39
|
0.03 10^12 cells per liter
Standard Deviation 0.206
|
0.04 10^12 cells per liter
Standard Deviation 0.253
|
SECONDARY outcome
Timeframe: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of hemoglobin level at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 1: n=78,74
|
0.5 Grams per liter
Standard Deviation 7.08
|
-0.7 Grams per liter
Standard Deviation 6.30
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 2: n=71, 74
|
0.5 Grams per liter
Standard Deviation 7.01
|
0.0 Grams per liter
Standard Deviation 5.64
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 4: n=49, 57
|
1.6 Grams per liter
Standard Deviation 8.84
|
-0.4 Grams per liter
Standard Deviation 5.16
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 6: n=44, 56
|
1.5 Grams per liter
Standard Deviation 4.60
|
-1.2 Grams per liter
Standard Deviation 5.17
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 8: n=34, 47
|
0.5 Grams per liter
Standard Deviation 6.16
|
-0.1 Grams per liter
Standard Deviation 6.72
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 10: n=34, 45
|
-0.4 Grams per liter
Standard Deviation 5.71
|
-0.8 Grams per liter
Standard Deviation 5.28
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 12: n=24, 39
|
1.0 Grams per liter
Standard Deviation 6.50
|
-1.8 Grams per liter
Standard Deviation 10.05
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 14: n=24, 39
|
-0.6 Grams per liter
Standard Deviation 6.08
|
-0.3 Grams per liter
Standard Deviation 6.35
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 16: n=24, 39
|
-0.5 Grams per liter
Standard Deviation 5.44
|
0.0 Grams per liter
Standard Deviation 6.14
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 28: n=65, 63
|
1.0 Grams per liter
Standard Deviation 8.20
|
-0.7 Grams per liter
Standard Deviation 10.24
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of hematocrit at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 1: n=78,74
|
0.0007 Proportion of red blood cells in blood
Standard Deviation 0.02255
|
-0.0025 Proportion of red blood cells in blood
Standard Deviation 0.02114
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 2: n=71, 74
|
0.0024 Proportion of red blood cells in blood
Standard Deviation 0.02213
|
-0.0046 Proportion of red blood cells in blood
Standard Deviation 0.04223
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 4: n=49, 57
|
0.0038 Proportion of red blood cells in blood
Standard Deviation 0.02957
|
-0.0033 Proportion of red blood cells in blood
Standard Deviation 0.01665
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 6: n=44, 56
|
0.0024 Proportion of red blood cells in blood
Standard Deviation 0.01557
|
-0.0050 Proportion of red blood cells in blood
Standard Deviation 0.02060
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 8: n=34, 47
|
-0.0019 Proportion of red blood cells in blood
Standard Deviation 0.01645
|
-0.0015 Proportion of red blood cells in blood
Standard Deviation 0.02212
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 10: n=34, 45
|
-0.0050 Proportion of red blood cells in blood
Standard Deviation 0.01897
|
-0.0061 Proportion of red blood cells in blood
Standard Deviation 0.02175
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 12: n=24, 39
|
0.0009 Proportion of red blood cells in blood
Standard Deviation 0.01740
|
-0.0088 Proportion of red blood cells in blood
Standard Deviation 0.03342
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 14: n=24, 39
|
-0.0018 Proportion of red blood cells in blood
Standard Deviation 0.01699
|
-0.0038 Proportion of red blood cells in blood
Standard Deviation 0.02277
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 16: n=24, 39
|
-0.0042 Proportion of red blood cells in blood
Standard Deviation 0.01474
|
-0.0071 Proportion of red blood cells in blood
Standard Deviation 0.02232
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Week 28: n=65, 63
|
0.0016 Proportion of red blood cells in blood
Standard Deviation 0.02283
|
-0.0041 Proportion of red blood cells in blood
Standard Deviation 0.03153
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of mean corpuscular hemoglobin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 4: n=49, 57
|
0.01 Picogram
Standard Deviation 0.461
|
-0.04 Picogram
Standard Deviation 0.432
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 6: n=44, 56
|
0.06 Picogram
Standard Deviation 0.416
|
0.00 Picogram
Standard Deviation 0.551
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 10: n=34, 45
|
-0.06 Picogram
Standard Deviation 0.590
|
-0.01 Picogram
Standard Deviation 0.863
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 1: n=78,74
|
0.17 Picogram
Standard Deviation 0.725
|
0.01 Picogram
Standard Deviation 0.453
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 2: n=71, 74
|
0.01 Picogram
Standard Deviation 0.430
|
-0.07 Picogram
Standard Deviation 0.471
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 8: n=34, 47
|
0.02 Picogram
Standard Deviation 0.660
|
-0.11 Picogram
Standard Deviation 0.567
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 12: n=24, 39
|
-0.07 Picogram
Standard Deviation 0.543
|
-0.12 Picogram
Standard Deviation 0.776
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 14: n=24, 39
|
-0.23 Picogram
Standard Deviation 0.421
|
-0.29 Picogram
Standard Deviation 0.785
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 16: n=24, 39
|
-0.05 Picogram
Standard Deviation 0.475
|
-0.26 Picogram
Standard Deviation 0.839
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Week 28: n=65, 63
|
-0.40 Picogram
Standard Deviation 0.649
|
-0.78 Picogram
Standard Deviation 1.773
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of mean corpuscular hemoglobin concentration at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 4: n=49, 57
|
1.2 Grams per liter
Standard Deviation 7.01
|
1.5 Grams per liter
Standard Deviation 7.32
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 1: n=78,74
|
0.8 Grams per liter
Standard Deviation 8.29
|
0.5 Grams per liter
Standard Deviation 6.65
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 2: n=71, 74
|
-0.6 Grams per liter
Standard Deviation 6.04
|
0.2 Grams per liter
Standard Deviation 7.09
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 6: n=44, 56
|
1.9 Grams per liter
Standard Deviation 5.33
|
1.3 Grams per liter
Standard Deviation 9.33
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 8: n=34, 47
|
3.0 Grams per liter
Standard Deviation 7.65
|
1.1 Grams per liter
Standard Deviation 7.56
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 10: n=34, 45
|
3.3 Grams per liter
Standard Deviation 6.68
|
3.4 Grams per liter
Standard Deviation 10.17
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 12: n=24, 39
|
2.3 Grams per liter
Standard Deviation 6.29
|
3.2 Grams per liter
Standard Deviation 10.32
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 14: n=24, 39
|
0.4 Grams per liter
Standard Deviation 6.47
|
2.4 Grams per liter
Standard Deviation 8.97
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 16: n=24, 39
|
2.1 Grams per liter
Standard Deviation 7.01
|
5.7 Grams per liter
Standard Deviation 9.60
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Week 28: n=65, 63
|
1.2 Grams per liter
Standard Deviation 8.36
|
1.5 Grams per liter
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of Erythrocytes Distribution Width (%) at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 8: n=34, 47
|
-0.40 Percentage (%) of Erythrocytes
Standard Deviation 0.669
|
-0.29 Percentage (%) of Erythrocytes
Standard Deviation 0.960
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 1: n=78,74
|
-0.06 Percentage (%) of Erythrocytes
Standard Deviation 0.747
|
-0.08 Percentage (%) of Erythrocytes
Standard Deviation 0.604
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 2: n=71, 74
|
-0.02 Percentage (%) of Erythrocytes
Standard Deviation 0.478
|
-0.20 Percentage (%) of Erythrocytes
Standard Deviation 0.652
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 4: n=49, 57
|
-0.22 Percentage (%) of Erythrocytes
Standard Deviation 0.555
|
-0.33 Percentage (%) of Erythrocytes
Standard Deviation 0.844
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 6: n=44, 56
|
-0.33 Percentage (%) of Erythrocytes
Standard Deviation 0.545
|
-0.37 Percentage (%) of Erythrocytes
Standard Deviation 0.861
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 10: n=34, 45
|
-0.35 Percentage (%) of Erythrocytes
Standard Deviation 0.791
|
-0.38 Percentage (%) of Erythrocytes
Standard Deviation 1.049
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 12: n=24, 39
|
-0.27 Percentage (%) of Erythrocytes
Standard Deviation 0.717
|
-0.34 Percentage (%) of Erythrocytes
Standard Deviation 0.916
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 14: n=24, 39
|
-0.28 Percentage (%) of Erythrocytes
Standard Deviation 0.873
|
-0.38 Percentage (%) of Erythrocytes
Standard Deviation 0.897
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 16: n=24, 39
|
-0.25 Percentage (%) of Erythrocytes
Standard Deviation 0.727
|
-0.41 Percentage (%) of Erythrocytes
Standard Deviation 0.995
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Week 28: n=65, 63
|
-0.09 Percentage (%) of Erythrocytes
Standard Deviation 1.028
|
-0.01 Percentage (%) of Erythrocytes
Standard Deviation 1.202
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of N-Terminal ProB-type Natriuretic Peptide at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=75 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 1: n=79,75
|
-14.8442 Nanograms per liter
Standard Deviation 61.92992
|
8.4023 Nanograms per liter
Standard Deviation 54.37938
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 2: n=73,75
|
-10.8134 Nanograms per liter
Standard Deviation 71.40009
|
-2.5196 Nanograms per liter
Standard Deviation 42.06499
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 4: n=49, 59
|
-17.9849 Nanograms per liter
Standard Deviation 68.85651
|
-4.5560 Nanograms per liter
Standard Deviation 44.12297
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 6: n=45, 57
|
-5.0620 Nanograms per liter
Standard Deviation 53.06025
|
3.6194 Nanograms per liter
Standard Deviation 53.96329
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 8: n=34, 47
|
-8.6398 Nanograms per liter
Standard Deviation 49.58134
|
9.6509 Nanograms per liter
Standard Deviation 66.34546
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 10: n=34, 46
|
-12.7377 Nanograms per liter
Standard Deviation 80.51666
|
14.9119 Nanograms per liter
Standard Deviation 58.17102
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 12: n=24, 38
|
-13.6951 Nanograms per liter
Standard Deviation 53.70314
|
8.8531 Nanograms per liter
Standard Deviation 58.15689
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 14: n=24, 39
|
-4.8082 Nanograms per liter
Standard Deviation 57.47926
|
20.0149 Nanograms per liter
Standard Deviation 74.94234
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 16: n=24, 39
|
-19.4899 Nanograms per liter
Standard Deviation 58.89689
|
4.7760 Nanograms per liter
Standard Deviation 60.56438
|
|
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Week 28: n=65, 65
|
-6.1970 Nanograms per liter
Standard Deviation 62.26132
|
0.9810 Nanograms per liter
Standard Deviation 64.44446
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected for the analysis of Troponin I at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=74 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 1: n=78,74
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
0.000 Micrograms per liter
Standard Deviation 0.0023
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 2: n=73, 73
|
0.000 Micrograms per liter
Standard Deviation 0.0016
|
0.000 Micrograms per liter
Standard Deviation 0.0023
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 4: n=49, 58
|
0.001 Micrograms per liter
Standard Deviation 0.0059
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 6: n=45, 57
|
0.000 Micrograms per liter
Standard Deviation 0.0021
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 8: n=34, 46
|
0.000 Micrograms per liter
Standard Deviation 0.0017
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 10: n=34, 38
|
0.006 Micrograms per liter
Standard Deviation 0.0344
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 12: n=24, 39
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 14: n=24, 39
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
0.000 Micrograms per liter
Standard Deviation 0.0016
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 16: n=24, 39
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
0.000 Micrograms per liter
Standard Deviation 0.0000
|
|
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Week 28: n=63, 63
|
0.000 Micrograms per liter
Standard Deviation 0.0013
|
-0.001 Micrograms per liter
Standard Deviation 0.0050
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and 28Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points and the presence of anti-GSK3772847 antibodies were assessed using a a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for participants who showed positive results for confirmation assay has been presented
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=75 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week2; n=73, 74
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week4; n=49, 59
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week8; n=34, 47
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week12; n=24, 39
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week16; n=23, 39
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week20; n=73, 75
|
1 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week24; n=74, 75
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Week28; n=74, 74
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4 (Pre-dose), 8 (Pre-dose), 12 (Pre-dose and Post-dose), 16, 20, 24 and 28Population: PK Population consists of all randomized participants who received at least one dose of study medication, and for whom at least one pharmacokinetic sample was obtained, analyzed and was measurable. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points to evaluate pharmacokinetics (PK) of GSK3772847 in participants with moderately severe asthma.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Serum Concentrations of GSK3772847
Week2; n=75
|
78.40 Micrograms per milliliter
Standard Deviation 30.934
|
—
|
|
Serum Concentrations of GSK3772847
Week4; Pre-dose;n=59
|
44.42 Micrograms per milliliter
Standard Deviation 21.774
|
—
|
|
Serum Concentrations of GSK3772847
Week8; Pre-dose; n= 47
|
61.44 Micrograms per milliliter
Standard Deviation 30.978
|
—
|
|
Serum Concentrations of GSK3772847
Week12; Pre-dose; n=39
|
63.42 Micrograms per milliliter
Standard Deviation 34.420
|
—
|
|
Serum Concentrations of GSK3772847
Week12; Post-dose; n=39
|
224.21 Micrograms per milliliter
Standard Deviation 151.780
|
—
|
|
Serum Concentrations of GSK3772847
Week16; n=38
|
63.03 Micrograms per milliliter
Standard Deviation 36.328
|
—
|
|
Serum Concentrations of GSK3772847
Week20; n=75
|
25.75 Micrograms per milliliter
Standard Deviation 19.074
|
—
|
|
Serum Concentrations of GSK3772847
Week24; n=75
|
12.91 Micrograms per milliliter
Standard Deviation 16.061
|
—
|
|
Serum Concentrations of GSK3772847
Week28; n=75
|
6.14 Micrograms per milliliter
Standard Deviation 16.005
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points to measure free soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=78 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Week12; Pre-dose; n=23, 37
|
10.5 Percent change
Interval -17.4 to 47.7
|
-92.5 Percent change
Interval -94.2 to -90.4
|
|
Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Week4; Pre-dose; n=48, 56
|
-5.6 Percent change
Interval -20.8 to 12.4
|
-93.8 Percent change
Interval -94.7 to -92.7
|
|
Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Week8; Pre-dose; n=33, 45
|
-8.5 Percent change
Interval -26.9 to 14.5
|
-93.5 Percent change
Interval -94.7 to -92.0
|
|
Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Week16; n=16, 26
|
19.8 Percent change
Interval -8.8 to 57.3
|
-92.0 Percent change
Interval -93.7 to -89.9
|
SECONDARY outcome
Timeframe: Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
Blood samples were collected at given time points to measure total soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=56 Participants
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Percent Change From Baseline in Total Soluble ST2 Concentration
Week4; Pre-dose; n=48, 56
|
16.3 Percent change
Interval -0.6 to 36.0
|
2691.1 Percent change
Interval 2314.4 to 3126.6
|
|
Percent Change From Baseline in Total Soluble ST2 Concentration
Week8; Pre-dose; n=33, 45
|
-6.9 Percent change
Interval -22.7 to 12.0
|
2326.9 Percent change
Interval 1951.7 to 2770.7
|
|
Percent Change From Baseline in Total Soluble ST2 Concentration
Week12; Pre-dose; n=23, 37
|
-13.4 Percent change
Interval -33.4 to 12.6
|
1858.0 Percent change
Interval 1461.4 to 2355.2
|
|
Percent Change From Baseline in Total Soluble ST2 Concentration
Week16; n=16, 26
|
-12.0 Percent change
Interval -28.5 to 8.3
|
2330.8 Percent change
Interval 1933.0 to 2806.4
|
Adverse Events
Placebo
GSK3772847
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 participants at risk
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/82 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
1.2%
1/83 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/82 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
0.00%
0/83 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/82 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
1.2%
1/83 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
GSK3772847
n=83 participants at risk
Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.9%
4/82 • Number of events 5 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
4.8%
4/83 • Number of events 6 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Infections and infestations
Influenza
|
4.9%
4/82 • Number of events 4 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
1.2%
1/83 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/82 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
4.8%
4/83 • Number of events 5 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Nervous system disorders
Headache
|
11.0%
9/82 • Number of events 15 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
10.8%
9/83 • Number of events 17 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/82 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
4.8%
4/83 • Number of events 5 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.7%
3/82 • Number of events 3 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
1.2%
1/83 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/82 • Number of events 1 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
3.6%
3/83 • Number of events 3 • SAEs and non-SAEs were collected for 16 weeks.
SAEs and non-SAEs were reported for Safety Population. The non-SAEs were reported using a frequency threshold of \>=3%.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER