Trial Outcomes & Findings for Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents (NCT NCT01159912)
NCT ID: NCT01159912
Last Updated: 2017-11-09
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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was 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 post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2017-11-09
Participant Flow
One participant received treatment (placebo) but was not randomized. Thus, 350 participants were enrolled in the study; however, only 349 were randomized.
Participants (par.) meeting all inclusion criteria/no exclusion criteria during Visit 1 entered a 4-week Run-in Period (RIP). At Visit 2 (end of RIP), par. meeting the eligibility criteria were randomized to the 24-week Double blind Treatment Period. 1036 par. were screened, 349 were randomized, and 343 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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
114
|
|
Overall Study
COMPLETED
|
75
|
92
|
88
|
|
Overall Study
NOT COMPLETED
|
40
|
22
|
26
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
23
|
15
|
14
|
|
Overall Study
Protocol Violation
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
3
|
Baseline Characteristics
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=114 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=114 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 17.68 • n=93 Participants
|
40.1 Years
STANDARD_DEVIATION 16.17 • n=4 Participants
|
41.4 Years
STANDARD_DEVIATION 15.64 • n=27 Participants
|
40.6 Years
STANDARD_DEVIATION 16.48 • n=483 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
203 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
140 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (HER)
|
23 participants
n=93 Participants
|
22 participants
n=4 Participants
|
19 participants
n=27 Participants
|
64 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER/South East Asian HER
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
88 participants
n=93 Participants
|
90 participants
n=4 Participants
|
92 participants
n=27 Participants
|
270 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native & White
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 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 a post-Baseline FEV1 measurement 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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was 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 post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Outcome measures
| Measure |
Placebo
n=113 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=111 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=107 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period
|
0.015 Liters
Standard Error 0.0394
|
0.161 Liters
Standard Error 0.0398
|
0.159 Liters
Standard Error 0.0406
|
SECONDARY outcome
Timeframe: Baseline and 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). Similarly, 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 use of rescue medication was considered to be rescue free. The Baseline value was derived from 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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=112 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). 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 at the End of the 24-week Treatment Period
|
6.5 Percentage of rescue-free 24-hr periods
Standard Error 2.82
|
21.3 Percentage of rescue-free 24-hr periods
Standard Error 2.85
|
24.3 Percentage of rescue-free 24-hr periods
Standard Error 2.83
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12 and 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. Trough evening PEF is the PM PEF measured approximately 24 hours after the last evening administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) 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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=112 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=112 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
PM PEF, Week 1 to 12
|
0.4 Liters/minute (L/min)
Standard Error 3.25
|
2.2 Liters/minute (L/min)
Standard Error 3.28
|
4.8 Liters/minute (L/min)
Standard Error 3.28
|
|
Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
PM PEF, Week 1 to 24
|
-1.3 Liters/minute (L/min)
Standard Error 3.36
|
1.5 Liters/minute (L/min)
Standard Error 3.39
|
4.3 Liters/minute (L/min)
Standard Error 3.40
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12 and 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 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) 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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=112 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
AM PEF, Week 1 to 24
|
5.0 Liters/minute (L/min)
Standard Error 3.45
|
13.9 Liters/minute (L/min)
Standard Error 3.48
|
9.9 Liters/minute (L/min)
Standard Error 3.47
|
|
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
AM PEF, Week 1 to 12
|
5.7 Liters/minute (L/min)
Standard Error 3.41
|
13.2 Liters/minute (L/min)
Standard Error 3.44
|
9.4 Liters/minute (L/min)
Standard Error 3.43
|
SECONDARY outcome
Timeframe: Baseline and 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). Similarly, 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. The Baseline value was derived from 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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=112 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=113 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). 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 at the End of the 24-week Treatment Period
|
10.4 Percentage of symptom-free 24-hr periods
Standard Error 2.77
|
19.3 Percentage of symptom-free 24-hr periods
Standard Error 2.79
|
19.2 Percentage of symptom-free 24-hr periods
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ \[+12\]) is a modified version of the AQLQ for use in asthma patients between the ages of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment." The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=114 Participants
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=114 Participants
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24
Week 12, n=85, 99, 99
|
0.45 Scores on a scale
Standard Error 0.078
|
0.69 Scores on a scale
Standard Error 0.072
|
0.73 Scores on a scale
Standard Error 0.073
|
|
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24
Week 24, n=74, 90, 86
|
0.51 Scores on a scale
Standard Error 0.090
|
0.84 Scores on a scale
Standard Error 0.082
|
0.67 Scores on a scale
Standard Error 0.084
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
FF 100 µg OD
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
FP 250 µg BID
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=114 participants at risk
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=114 participants at risk
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.87%
1/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Abscess
|
0.00%
0/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Meningitis
|
0.87%
1/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, 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 and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FF 100 µg OD
n=114 participants at risk
Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
FP 250 µg BID
n=114 participants at risk
Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
6.1%
7/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
7.0%
8/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
3.5%
4/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
6/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
7.9%
9/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
3.5%
4/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
6/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
6.1%
7/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
5.3%
6/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
3.5%
4/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
4.4%
5/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
1.8%
2/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.87%
1/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
3.5%
4/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
1.8%
2/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
4/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.88%
1/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
4.3%
5/115 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
6.1%
7/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
6.1%
7/114 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Week 24).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who 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