FFA115285

GlaxoSmithKline

980 Great West Road, Brentford, Middlesex, United Kingdom,

GSK Response Center, GlaxoSmithKline, +1 8664357343,

GSK Response Center, GlaxoSmithKline, +1 8664357343,

No

No

No

Final

29 Oct 2012

No

Yes

26 Sep 2012

No

To evaluate the efficacy and safety of inhaled fluticasone furoate 50 mcg administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 24-week treatment period.

Participant withdrawal due to lack of efficacy was required when: A participant’s clinic FEV1 fell below the FEV1 stability limit value calculated at Visit 2; In the 7 days immediately preceding any contact, the subject experienced: at least 4 days in which the AM or PM PEF fell below the PEF stability limit calculated at Visit 2 and/or at least 3 days in which >=12 inhalations/day of albuterol/salbutamol were used; A participant experienced a protocol-defined severe asthma exacerbation.

21 Sep 2011

No

No

Russian Federation: 53

United States: 232

Netherlands: 38

Poland: 86

Mexico: 96

Peru: 150

655

124

0

0

0

0

0

96

525

34

0

Overall Study (overall period)

Randomised - controlled

Yes

Placebo

Inhalation powder

Inhalation use

Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks.

FF 50 µg

Inhalation powder

Inhalation use

Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks.

FP 100 µg

Inhalation powder

Inhalation use

Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks.

Placebo

FF 50 µg OD

FP 100 µg BID

Placebo

FF 50 µg OD

FP 100 µg BID

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.

Primary

Baseline and Week 24

Placebo v FF 50 µg OD

227

Pre-specified

0.037

2-sided

Placebo v FP 100 µg BID

223

Pre-specified

2-sided

The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Secondary

From Baseline up to 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 average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Secondary

From Baseline up to 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 the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Secondary

From Baseline up to Week 24

Asthma symptoms were recorded in a daily eDiary by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Secondary

From Baseline up to Week 24

The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.

Secondary

From the first dose of the study medication until Week 24/Early Withdrawal

On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.

Serious AEs (SAEs) and non-serious AEs were collected in the ITT, comprised of all participants randomized to treatment who received at least one dose of study medication.

15.0

Placebo

FF 50 µg OD

FP 100 µg BID