Asthma
Conditions
Keywords
fluticasone propionate, Fluticasone furoate
Brief summary
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Detailed description
This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.
Interventions
DRUGFluticasone propionate
Fluticasone propionate inhalation powder, 250 µg
DRUGFluticasone furoate
Fluticasone furoate inhalation powder, 100 µg
DRUGPlacebo
Placebo inhalation powder
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Outpatient at least 12 years of age * Both genders; females of child bearing potential must be willing to use approved birth control method * Pre-bronchodilator FEV1 of 40-90% predicted * Reversibility FEV1 of at least 12% and 200mLs * Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit
Exclusion criteria
* History of life threatening asthma * Respiratory infection or candidiasis * Asthma exacerbation within 6 months prior to first visit * Concurrent respiratory disease or other disease that would confound study participation or affect subject safety * Allergies to study drugs, study drug excipients, medications related to study drugs * Taking another investigational medication or medication prohibited for use during this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period | Baseline and Week 24 | 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. |
| 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 | From Baseline up to Week 12 and Week 24 | 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. |
| Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period | From Baseline up to Week 12 and Week 24 | 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. |
| Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period | Baseline and Week 24 | 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. |
| Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24 | Baseline, Week 12, and Week 24 | 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. |
Countries
Belgium, Germany, Poland, Romania, United States
Participant flow
Recruitment details
One participant received treatment (placebo) but was not randomized. Thus, 350 participants were enrolled in the study; however, only 349 were randomized.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 115 |
| 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. | 114 |
| 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. | 114 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 3 |
| Overall Study | Lack of Efficacy | 23 | 15 | 14 |
| Overall Study | Lost to Follow-up | 4 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 3 |
| Overall Study | Protocol Violation | 1 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 10 | 3 | 3 |
Baseline characteristics
| Characteristic | Placebo | FF 100 µg OD | FP 250 µg BID | Total |
|---|---|---|---|---|
| Age, Continuous | 40.3 Years STANDARD_DEVIATION 17.68 | 40.1 Years STANDARD_DEVIATION 16.17 | 41.4 Years STANDARD_DEVIATION 15.64 | 40.6 Years STANDARD_DEVIATION 16.48 |
| Race/Ethnicity, Customized African American/African Heritage (HER) | 23 participants | 22 participants | 19 participants | 64 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native & White | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Central/South Asian Heritage | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER | 1 participants | 1 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Missing | 0 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 88 participants | 90 participants | 92 participants | 270 participants |
| Sex: Female, Male Female | 68 Participants | 63 Participants | 72 Participants | 203 Participants |
| Sex: Female, Male Male | 47 Participants | 51 Participants | 42 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 115 | 37 / 114 | 19 / 114 |
| serious Total, serious adverse events | 2 / 115 | 4 / 114 | 1 / 114 |
Outcome results
Primary
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
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| FF 100 µg OD | 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 | 0.161 Liters | Standard Error 0.0398 |
| FP 250 µg BID | 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 | 0.159 Liters | Standard Error 0.0406 |
p-value: 0.01195% CI: [0.033, 0.257]ANCOVA
p-value: 0.00995% CI: [0.036, 0.257]ANCOVA
Secondary
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period
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.
Time frame: Baseline and Week 24
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| FF 100 µg OD | Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period | 21.3 Percentage of rescue-free 24-hr periods | Standard Error 2.85 |
| FP 250 µg BID | Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period | 24.3 Percentage of rescue-free 24-hr periods | Standard Error 2.83 |
Secondary
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period
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.
Time frame: Baseline and Week 24
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| FF 100 µg OD | Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period | 19.3 Percentage of symptom-free 24-hr periods | Standard Error 2.79 |
| FP 250 µg BID | Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period | 19.2 Percentage of symptom-free 24-hr periods | Standard Error 2.78 |
Secondary
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24
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.
Time frame: Baseline, Week 12, and Week 24
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 0.09 |
| FF 100 µg OD | 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 | 0.69 Scores on a scale | Standard Error 0.072 |
| FF 100 µg OD | 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 | 0.84 Scores on a scale | Standard Error 0.082 |
| FP 250 µg BID | 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 | 0.73 Scores on a scale | Standard Error 0.073 |
| FP 250 µg BID | 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 | 0.67 Scores on a scale | Standard Error 0.084 |
Secondary
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
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.
Time frame: From Baseline up to Week 12 and Week 24
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| FF 100 µg OD | 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 | 13.2 Liters/minute (L/min) | Standard Error 3.44 |
| FF 100 µg OD | 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 | 13.9 Liters/minute (L/min) | Standard Error 3.48 |
| FP 250 µg BID | 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 | 9.4 Liters/minute (L/min) | Standard Error 3.43 |
| FP 250 µg BID | 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 | 9.9 Liters/minute (L/min) | Standard Error 3.47 |
Secondary
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
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.
Time frame: From Baseline up to Week 12 and Week 24
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| FF 100 µg OD | 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 | 2.2 Liters/minute (L/min) | Standard Error 3.28 |
| FF 100 µg OD | 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 | 1.5 Liters/minute (L/min) | Standard Error 3.39 |
| FP 250 µg BID | 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 | 4.8 Liters/minute (L/min) | Standard Error 3.28 |
| FP 250 µg BID | 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 | 4.3 Liters/minute (L/min) | Standard Error 3.4 |