Trial Outcomes & Findings for Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma (NCT NCT03012061)
NCT ID: NCT03012061
Last Updated: 2020-10-28
Results Overview
FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
425 participants
Primary outcome timeframe
Baseline (Day 1 pre-dose) and Week 24
Results posted on
2020-10-28
Participant Flow
This study was conducted at different centers in Russia, United States, Canada, Poland and Romania to compare the efficacy, safety and tolerability of two doses of umeclidinium bromide (UMEC) administered once-daily (OD) via a dry powder inhaler, versus placebo.
Total 421 participants were included in the study.
Participant milestones
| Measure |
Placebo QD
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
143
|
139
|
139
|
|
Overall Study
COMPLETED
|
137
|
130
|
131
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
8
|
Reasons for withdrawal
| Measure |
Placebo QD
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
4
|
|
Overall Study
Investigator Site Closed
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Study closed/ Terminated
|
0
|
0
|
1
|
|
Overall Study
Met Protocol Withdrawal Criterion
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
Baseline Characteristics
Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Placebo QD
n=143 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=139 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
Total
n=421 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 15.83 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 14.21 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 14.64 • n=4 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
298 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian; Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian; East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian; South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White: Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White: White/Caucasian/European Heritage
|
131 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
386 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American & White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Week 24Population: Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. All on- and post-treatment data was included. Different participants may have been analyzed at different time points.
FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.
Outcome measures
| Measure |
Placebo QD
n=141 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=136 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
|
0.1289 Liters
Standard Error 0.0298
|
0.3046 Liters
Standard Error 0.0304
|
0.3130 Liters
Standard Error 0.0302
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Week 24Population: Intent-to-Treat Population. Only those participants with available on-treatment data at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 2 pre-dose or from Visit 1 pre-bronchodilator). Change from Baseline was calculated as FEV1 value at Week 24 (recorded at 3 hours post dose) minus FEV1 value at Baseline. The analysis only including data collected on-treatment. LS mean change and SE data is presented.
Outcome measures
| Measure |
Placebo QD
n=133 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=127 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=129 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Dose at Week 24
|
0.1768 Liters
Standard Error 0.0318
|
0.3663 Liters
Standard Error 0.0325
|
0.3744 Liters
Standard Error 0.0322
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Intent-to-Treat Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs and serious adverse events (SAE) and common (\>=3%)non-SAEs have been reported.
Outcome measures
| Measure |
Placebo QD
n=143 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=139 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)
Any AE
|
65 Participants
|
73 Participants
|
57 Participants
|
|
Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)
Any SAE
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)
Any non-SAE
|
39 Participants
|
47 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 24Population: Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
A single 12-lead ECG and rhythm strip was recorded after measurement of vital signs and spirometry at given time points. All ECG measurements were measured with participants in supine position after \>=5 minutes rest. All ECGs were electronically transmitted to an independent and treatment-blinded cardiologist for the measurement. ECG was obtained 15 minutes to 45 minutes after the administration of study treatment. Data for number of participants with abnormal ECG Findings have been reported.
Outcome measures
| Measure |
Placebo QD
n=143 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=139 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings
Week 4, n=139, 135, 138
|
23 Participants
|
26 Participants
|
35 Participants
|
|
Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings
Week 24, n=133, 129, 129
|
26 Participants
|
23 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Weeks 4, 12 and 24Population: Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood pressure was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Blood pressure was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented. Different participants may have data available at different time points; thus, the overall number of participants analyzed reflects everyone in the ITT Population without missing covariate information and with a Baseline and at least one post-Baseline measurement.
Outcome measures
| Measure |
Placebo QD
n=139 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=137 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 4, n=139, 137, 139
|
-0.7 Millimeters of mercury
Standard Error 0.70
|
1.1 Millimeters of mercury
Standard Error 0.71
|
0.3 Millimeters of mercury
Standard Error 0.70
|
|
Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 12, n=139, 133, 135
|
0.3 Millimeters of mercury
Standard Error 0.78
|
-0.2 Millimeters of mercury
Standard Error 0.79
|
0.6 Millimeters of mercury
Standard Error 0.79
|
|
Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 24, n=135, 131, 130
|
-0.6 Millimeters of mercury
Standard Error 0.77
|
1.1 Millimeters of mercury
Standard Error 0.78
|
-0.1 Millimeters of mercury
Standard Error 0.79
|
|
Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 4, n=139, 137, 139
|
0.4 Millimeters of mercury
Standard Error 0.55
|
1.2 Millimeters of mercury
Standard Error 0.56
|
0.6 Millimeters of mercury
Standard Error 0.55
|
|
Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 12, n=139, 133, 135
|
0.7 Millimeters of mercury
Standard Error 0.57
|
0.2 Millimeters of mercury
Standard Error 0.59
|
1.8 Millimeters of mercury
Standard Error 0.58
|
|
Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 24, n=135, 131, 130
|
-0.1 Millimeters of mercury
Standard Error 0.57
|
1.6 Millimeters of mercury
Standard Error 0.58
|
1.4 Millimeters of mercury
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Weeks 4, 12 and 24Population: Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Participants with data available at the specified time points are represented by (n=X) in the category titles.
Pulse rate was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Pulse rate was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented.
Outcome measures
| Measure |
Placebo QD
n=139 Participants
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=137 Participants
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 Participants
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in On-treatment Pulse Rate
Week 4, n=139, 137, 139
|
-2.3 Beats per minute
Standard Error 0.69
|
-1.0 Beats per minute
Standard Error 0.69
|
-0.8 Beats per minute
Standard Error 0.69
|
|
Mean Change From Baseline in On-treatment Pulse Rate
Week 12, n=139, 133, 135
|
-0.9 Beats per minute
Standard Error 0.59
|
-0.3 Beats per minute
Standard Error 0.60
|
0.8 Beats per minute
Standard Error 0.60
|
|
Mean Change From Baseline in On-treatment Pulse Rate
Week 24, n=135, 131, 130
|
-1.8 Beats per minute
Standard Error 0.75
|
-0.7 Beats per minute
Standard Error 0.76
|
1.5 Beats per minute
Standard Error 0.76
|
Adverse Events
Placebo QD
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
UMEC 31.25 mcg QD
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
UMEC 62.5 mcg QD
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QD
n=143 participants at risk
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=139 participants at risk
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 participants at risk
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
2/143 • Number of events 2 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Vascular disorders
Hypertension
|
1.4%
2/143 • Number of events 2 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Nervous system disorders
Transient Ischemic attack
|
0.70%
1/143 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/143 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
Other adverse events
| Measure |
Placebo QD
n=143 participants at risk
Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 31.25 mcg QD
n=139 participants at risk
Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
UMEC 62.5 mcg QD
n=139 participants at risk
Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.9%
17/143 • Number of events 21 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
10.1%
14/139 • Number of events 20 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
9.4%
13/139 • Number of events 15 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
3/143 • Number of events 3 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
5.8%
8/139 • Number of events 13 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
4.3%
6/139 • Number of events 8 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.5%
5/143 • Number of events 5 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
5.0%
7/139 • Number of events 9 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
2.9%
4/139 • Number of events 4 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Nervous system disorders
Headache
|
7.7%
11/143 • Number of events 22 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
6.5%
9/139 • Number of events 14 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
8.6%
12/139 • Number of events 17 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
2/143 • Number of events 2 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
4.3%
6/139 • Number of events 6 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
2.9%
4/139 • Number of events 6 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.4%
2/143 • Number of events 2 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
4.3%
6/139 • Number of events 7 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.00%
0/139 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
5/143 • Number of events 5 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
2.2%
3/139 • Number of events 3 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.70%
1/143 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
3.6%
5/139 • Number of events 6 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
1.4%
2/139 • Number of events 2 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
4/143 • Number of events 5 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
0.72%
1/139 • Number of events 1 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
3.6%
5/139 • Number of events 5 • On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Intent-to-Treat Population was used to collect adverse events.
|
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