Trial Outcomes & Findings for A Dose-ranging Study of Fluticasone Furoate (FF) (NCT NCT01563029)
NCT ID: NCT01563029
Last Updated: 2017-05-30
Results Overview
PEF 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 prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
597 participants
Primary outcome timeframe
Baseline; Week 1 up to Week 12
Results posted on
2017-05-30
Participant Flow
1540 participants were screened, 596 participants were randomized, and 593 participants comprise the Intent to Treat Population which include all participants who received at least one dose of study treatment. Participants were stratified at randomization according to their prior inhaled corticosteroid (ICS) use.
Participants who met the eligibility criteria at screening (Visit 1) entered a 4-week Run-in Period during which they continued their existing medications. Participants who met the randomization criteria (remained uncontrolled despite baseline therapy) at Visit 3 were randomized to 1 of 5 treatment arms for 12 weeks followed by a 1-week follow-up.
Participant milestones
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 50 µg OD
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
119
|
118
|
120
|
118
|
118
|
|
Overall Study
COMPLETED
|
66
|
94
|
87
|
85
|
89
|
|
Overall Study
NOT COMPLETED
|
53
|
24
|
33
|
33
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 50 µg OD
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
42
|
16
|
23
|
21
|
19
|
|
Overall Study
Protocol Violation
|
1
|
2
|
3
|
1
|
3
|
|
Overall Study
Protocol defined stopping criteria
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
3
|
5
|
2
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
4
|
3
|
Baseline Characteristics
A Dose-ranging Study of Fluticasone Furoate (FF)
Baseline characteristics by cohort
| Measure |
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=118 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 50 µg OD
n=120 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=118 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.0 Years
STANDARD_DEVIATION 1.91 • n=5 Participants
|
7.9 Years
STANDARD_DEVIATION 2.08 • n=7 Participants
|
8.4 Years
STANDARD_DEVIATION 1.62 • n=5 Participants
|
7.8 Years
STANDARD_DEVIATION 2.04 • n=4 Participants
|
7.9 Years
STANDARD_DEVIATION 1.87 • n=21 Participants
|
8.0 Years
STANDARD_DEVIATION 1.92 • n=10 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
223 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
370 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
95 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian -Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
47 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
247 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
187 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 1 up to Week 12Population: ITT Population: participants randomized to treatment who received at least 1 dose of study medication. Only participants available at the specified time points were analyzed.
PEF 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 prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.
Outcome measures
| Measure |
FF 50 µg OD
n=118 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=117 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
n=236 Participants
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period
|
22.8 Liters per minute (L/min)
Standard Deviation 2.65
|
3.3 Liters per minute (L/min)
Standard Deviation 2.63
|
21.9 Liters per minute (L/min)
Standard Deviation 2.66
|
15.8 Liters per minute (L/min)
Standard Deviation 2.64
|
17.3 Liters per minute (L/min)
Standard Deviation 2.64
|
19.3 Liters per minute (L/min)
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT Population. Only participants available at the specified time points were analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
FF 50 µg OD
n=112 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=102 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=96 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=96 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=102 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period in Children Who Could Perform the Maneuver
|
0.150 Liters
Standard Error 0.0252
|
0.128 Liters
Standard Error 0.0264
|
0.254 Liters
Standard Error 0.0272
|
0.162 Liters
Standard Error 0.0272
|
0.192 Liters
Standard Error 0.0262
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 1 up to Week 12Population: ITT Population. Only participants available at the specified time points were analyzed.
The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. The Baseline rescue-free value was defined as the percentage of rescue-free 24-hr periods from the last 7 days of the Run-in Period. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.
Outcome measures
| Measure |
FF 50 µg OD
n=118 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=117 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period
|
26.3 Percentage of rescue-free 24-hr periods
Standard Error 3.03
|
16.5 Percentage of rescue-free 24-hr periods
Standard Error 3.01
|
24.9 Percentage of rescue-free 24-hr periods
Standard Error 3.03
|
28.7 Percentage of rescue-free 24-hr periods
Standard Error 3.02
|
22.7 Percentage of rescue-free 24-hr periods
Standard Error 3.01
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 1 up to Week 12Population: ITT Population. Only participants available at the specified time points were analyzed.
PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.
Outcome measures
| Measure |
FF 50 µg OD
n=119 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=117 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period
|
18.5 liters per minute (L/min)
Standard Error 2.77
|
5.1 liters per minute (L/min)
Standard Error 2.76
|
16.3 liters per minute (L/min)
Standard Error 2.81
|
13.5 liters per minute (L/min)
Standard Error 2.78
|
13.1 liters per minute (L/min)
Standard Error 2.77
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: ITT Population. Only participants available at the specified time points were analyzed.
PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.
Outcome measures
| Measure |
FF 50 µg OD
n=118 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=117 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)
|
18.2 L/min
Standard Error 3.77
|
5.0 L/min
Standard Error 3.75
|
16.2 L/min
Standard Error 3.80
|
11.0 L/min
Standard Error 3.76
|
11.3 L/min
Standard Error 3.75
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: ITT Population. Only participants available at the specified time points were analyzed.
PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.
Outcome measures
| Measure |
FF 50 µg OD
n=118 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=117 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)
|
20.6 L/min
Standard Error 3.83
|
2.7 L/min
Standard Error 3.81
|
23.3 L/min
Standard Error 3.85
|
14.2 L/min
Standard Error 3.82
|
19.3 L/min
Standard Error 3.82
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 1 up to Week 12Population: ITT Population. Only 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 PEF measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the percentage of symptom free 24-hr periods in the last 7 days of the run-in period. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.
Outcome measures
| Measure |
FF 50 µg OD
n=119 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=117 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=117 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period
|
24.7 Percentage of symptom-free 24-hr periods
Standard Error 2.90
|
19.0 Percentage of symptom-free 24-hr periods
Standard Error 2.90
|
21.0 Percentage of symptom-free 24-hr periods
Standard Error 2.92
|
22.9 Percentage of symptom-free 24-hr periods
Standard Error 2.91
|
22.0 Percentage of symptom-free 24-hr periods
Standard Error 2.91
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12Population: ITT Population
The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.
Outcome measures
| Measure |
FF 50 µg OD
n=120 Participants
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Placebo
n=119 Participants
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=118 Participants
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 Participants
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=118 Participants
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
Average of FF 50 µg OD and FF 100 µg OD
All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|---|
|
Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period
|
23 Participants
|
42 Participants
|
16 Participants
|
21 Participants
|
19 Participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
FF 25 µg OD
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
FF 50 µg OD
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
FF 100 µg OD
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
FP 100 µg BID
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=119 participants at risk
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=118 participants at risk
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 50 µg OD
n=120 participants at risk
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 participants at risk
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=118 participants at risk
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|
|
Infections and infestations
Hepatitis A
|
0.00%
0/119 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/120 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.85%
1/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/119 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.83%
1/120 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=119 participants at risk
Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 25 µg OD
n=118 participants at risk
Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 50 µg OD
n=120 participants at risk
Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FF 100 µg OD
n=118 participants at risk
Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
FP 100 µg BID
n=118 participants at risk
Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
6/119 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.9%
7/118 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.83%
1/120 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
8.5%
10/118 • Number of events 12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
4.2%
5/118 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
4/119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
7.6%
9/118 • Number of events 12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.3%
4/120 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
2.5%
3/118 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.4%
4/118 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
2/119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.1%
6/118 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.83%
1/120 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.1%
6/118 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
4.2%
5/118 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
3.4%
4/119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.8%
7/120 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
4.2%
5/118 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.85%
1/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
1.7%
2/119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/120 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.9%
7/118 • Number of events 10 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.4%
4/118 • Number of events 10 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.84%
1/119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
5.1%
6/118 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/120 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.4%
4/118 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.84%
1/119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.3%
4/120 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
3/119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.85%
1/118 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/120 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.4%
4/118 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
2.5%
3/118 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/119 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.4%
4/118 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.83%
1/120 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
1.7%
2/118 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.85%
1/118 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
|
Investigations
Body temperature increased
|
0.00%
0/119 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
2.5%
3/118 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/120 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
0.00%
0/118 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
3.4%
4/118 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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