Trial Outcomes & Findings for Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma (NCT NCT01436110)
NCT ID: NCT01436110
Last Updated: 2017-01-09
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
COMPLETED
PHASE3
351 participants
Baseline and Week 24
2017-01-09
Participant Flow
Participants meeting eligibility criteria at the Screening visit entered a 2-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 24-week Treatment Period. A total of 655 participants were screened; 351 were randomized, and 347 received \>=1 dose of study treatment.
Participant milestones
| Measure |
Placebo
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
117
|
118
|
|
Overall Study
Intent-to-Treat Population
|
115
|
117
|
115
|
|
Overall Study
COMPLETED
|
77
|
91
|
95
|
|
Overall Study
NOT COMPLETED
|
39
|
26
|
23
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
23
|
14
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
4
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Physician Decision
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
|
Overall Study
Did Not Receive Trial Medication
|
1
|
0
|
3
|
Baseline Characteristics
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=115 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.6 Years
STANDARD_DEVIATION 18.03 • n=5 Participants
|
35.4 Years
STANDARD_DEVIATION 14.64 • n=7 Participants
|
36.2 Years
STANDARD_DEVIATION 16.95 • n=5 Participants
|
36.4 Years
STANDARD_DEVIATION 16.57 • n=4 Participants
|
|
Gender
Female
|
81 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Gender
Male
|
34 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data 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. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Outcome measures
| Measure |
Placebo
n=111 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=116 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=112 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
|
0.089 Liters
Standard Error 0.0331
|
0.126 Liters
Standard Error 0.0323
|
0.191 Liters
Standard Error 0.0328
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=114 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=116 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period
|
21.1 Percentage of rescue-free 24-hr periods
Standard Error 3.20
|
28.9 Percentage of rescue-free 24-hr periods
Standard Error 3.17
|
31.7 Percentage of rescue-free 24-hr periods
Standard Error 3.21
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=114 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=116 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period
|
7.6 Liters/minute (L/min)
Standard Error 4.08
|
24.9 Liters/minute (L/min)
Standard Error 4.04
|
12.0 Liters/minute (L/min)
Standard Error 4.09
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=114 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=116 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period
|
10.8 L/min
Standard Error 3.85
|
30.0 L/min
Standard Error 3.81
|
21.4 L/min
Standard Error 3.86
|
SECONDARY outcome
Timeframe: From Baseline up to Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Outcome measures
| Measure |
Placebo
n=114 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=116 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period
|
16.8 Percentage of symptom-free 24-hr periods
Standard Error 2.88
|
25.1 Percentage of symptom-free 24-hr periods
Standard Error 2.85
|
24.3 Percentage of symptom-free 24-hr periods
Standard Error 2.88
|
SECONDARY outcome
Timeframe: From the first dose of the study medication until Week 24/Early WithdrawalPopulation: ITT Population
The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of \>=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 \* 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 \* 80%.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=115 Participants
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period
|
23 Participants
|
14 Participants
|
9 Participants
|
Adverse Events
Placebo
FF 50 µg OD
FP 100 µg BID
Serious adverse events
| Measure |
Placebo
n=115 participants at risk
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=117 participants at risk
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=115 participants at risk
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
1/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.87%
1/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.87%
1/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.87%
1/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=115 participants at risk
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 50 µg OD
n=117 participants at risk
Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 100 µg BID
n=115 participants at risk
Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.2%
6/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
6.8%
8/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
10.4%
12/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
8.7%
10/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
6.0%
7/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.3%
5/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
3/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.1%
6/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.2%
6/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
3.5%
4/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
3.4%
4/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.2%
6/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
11.3%
13/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
14.5%
17/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
10.4%
12/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
6/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
1.7%
2/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
4/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
1.7%
2/117 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.87%
1/115 • On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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