Trial Outcomes & Findings for Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma (NCT NCT00766090)
NCT ID: NCT00766090
Last Updated: 2016-12-08
Results Overview
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
Day 28 of the relevant treatment period (up to Study Day 112)
Results posted on
2016-12-08
Participant Flow
Eligible participants (par.) at screening entered a 14-day Run-in Period. Par. were then randomized to 1 of 12 sequences: 6 had placebo and two doses of fluticasone furoate (FF), and 6 had placebo and two doses of fluticasone proprionate (FP) (allocation ratio of 7:2 \[FF:FP\]). 320 par. were screened and 190 were randomized.
Participant milestones
| Measure |
Sequence 1: Placebo, FF 200 µg, FF 100 µg
Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 2: Placebo, FF 100 µg, FF 200 µg
Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 3: FF 100 µg, Placebo, FF 200 µg
Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 4: FF 100 µg, FF 200 µg, Placebo
Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 5: FF 200 µg, Placebo, FF 100 µg
Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 6: FF 200 µg, FF 100 µg, Placebo
Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 7: Placebo, FP 200 µg, FP 100 µg
Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 8: Placebo, FP 100 µg, FP 200 µg
Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 9: FP 100 µg, Placebo, FP 200 µg
Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 10: FP 100 µg, FP 200 µg, Placebo
Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 11: FP 200 µg, Placebo, FP 100 µg
Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 12: FP 200 µg, FP 100 µg, Placebo
Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (28 Days)
STARTED
|
25
|
27
|
23
|
26
|
23
|
23
|
6
|
8
|
7
|
8
|
7
|
7
|
|
Treatment Period 1 (28 Days)
COMPLETED
|
22
|
27
|
23
|
25
|
23
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Treatment Period 1 (28 Days)
NOT COMPLETED
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 1 (14 Days)
STARTED
|
22
|
27
|
23
|
25
|
23
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Washout Period 1 (14 Days)
COMPLETED
|
22
|
27
|
22
|
25
|
23
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Washout Period 1 (14 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (28 Days)
STARTED
|
22
|
27
|
22
|
25
|
23
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Treatment Period 2 (28 Days)
COMPLETED
|
22
|
27
|
21
|
25
|
21
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Treatment Period 2 (28 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (14 Days)
STARTED
|
22
|
27
|
21
|
25
|
21
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Washout Period 2 (14 Days)
COMPLETED
|
22
|
27
|
20
|
25
|
21
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Washout Period 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (28 Days)
STARTED
|
22
|
27
|
20
|
25
|
21
|
23
|
6
|
8
|
6
|
8
|
7
|
7
|
|
Treatment Period 3 (28 Days)
COMPLETED
|
22
|
26
|
20
|
24
|
20
|
22
|
6
|
8
|
6
|
8
|
7
|
6
|
|
Treatment Period 3 (28 Days)
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1: Placebo, FF 200 µg, FF 100 µg
Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 2: Placebo, FF 100 µg, FF 200 µg
Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 3: FF 100 µg, Placebo, FF 200 µg
Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 4: FF 100 µg, FF 200 µg, Placebo
Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 5: FF 200 µg, Placebo, FF 100 µg
Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 6: FF 200 µg, FF 100 µg, Placebo
Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 7: Placebo, FP 200 µg, FP 100 µg
Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 8: Placebo, FP 100 µg, FP 200 µg
Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 9: FP 100 µg, Placebo, FP 200 µg
Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 10: FP 100 µg, FP 200 µg, Placebo
Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 11: FP 200 µg, Placebo, FP 100 µg
Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Sequence 12: FP 200 µg, FP 100 µg, Placebo
Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (28 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1 (28 Days)
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (28 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (14 Days)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (28 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (28 Days)
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (14 Days)
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (28 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (28 Days)
Lack of Efficacy
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3 (28 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
Baseline characteristics by cohort
| Measure |
FF 200 µg, FF 100 µg, and Placebo Via DPI
n=147 Participants
Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg, FP 100 µg, and Placebo Via DISKUS
n=43 Participants
Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 Years
STANDARD_DEVIATION 15.30 • n=93 Participants
|
35.2 Years
STANDARD_DEVIATION 16.03 • n=4 Participants
|
32.3 Years
STANDARD_DEVIATION 15.51 • n=27 Participants
|
|
Gender
Female
|
87 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Gender
Male
|
60 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (HER)
|
50 participants
n=93 Participants
|
20 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian (AI) or Alaska Native (AN)
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER/South East Asian HER
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
90 participants
n=93 Participants
|
22 participants
n=4 Participants
|
112 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African HER & AI or AN & White
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 28 of the relevant treatment period (up to Study Day 112)Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Outcome measures
| Measure |
Placebo
n=187 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=140 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=142 Participants
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=42 Participants
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=43 Participants
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
|
2.605 Liters
Standard Error 0.0434
|
2.714 Liters
Standard Error 0.0444
|
2.703 Liters
Standard Error 0.0443
|
2.693 Liters
Standard Error 0.0535
|
2.737 Liters
Standard Error 0.0533
|
SECONDARY outcome
Timeframe: From the first dose of the study medication up to Week 16/Early WithdrawalPopulation: ITT Population
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold \>=3%) and SAEs.
Outcome measures
| Measure |
Placebo
n=187 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=140 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=142 Participants
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=42 Participants
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=43 Participants
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
Any AE
|
26 participants
|
22 participants
|
26 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
Any SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 28 of the relevant treatment period (up to Study Day 112)Population: Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results
A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=118 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=116 Participants
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=35 Participants
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=39 Participants
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
|
53.94 Nanomoles per 24 hours
Geometric Coefficient of Variation 66.423
|
40.25 Nanomoles per 24 hours
Geometric Coefficient of Variation 92.316
|
45.13 Nanomoles per 24 hours
Geometric Coefficient of Variation 87.181
|
56.16 Nanomoles per 24 hours
Geometric Coefficient of Variation 94.259
|
47.56 Nanomoles per 24 hours
Geometric Coefficient of Variation 84.896
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)Population: ITT Population. Only those participants available at the specified time points were analyzed.
Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Outcome measures
| Measure |
Placebo
n=187 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=140 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=142 Participants
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=42 Participants
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=43 Participants
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Day 0: Yes, n=187, 140, 142, 42, 43
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Day 0: No, n=187, 140, 142, 42, 43
|
187 participants
|
140 participants
|
142 participants
|
42 participants
|
43 participants
|
|
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Day 28: Yes, n=178, 139, 140, 42, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Day 28: No, n=178, 139, 140, 42, 42
|
178 participants
|
139 participants
|
140 participants
|
42 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)Population: ITT Population. Only those participants available at the specified time points were analyzed.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Outcome measures
| Measure |
Placebo
n=187 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=140 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=142 Participants
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=42 Participants
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=43 Participants
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
DBP: Day 28, n=178, 139, 140, 42, 42
|
75.8 millimeters of mercury (mmHg)
Standard Deviation 8.45
|
74.9 millimeters of mercury (mmHg)
Standard Deviation 8.12
|
76.4 millimeters of mercury (mmHg)
Standard Deviation 7.97
|
76.0 millimeters of mercury (mmHg)
Standard Deviation 7.81
|
75.7 millimeters of mercury (mmHg)
Standard Deviation 8.90
|
|
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
SBP: Day 0, n=187, 140, 142, 42, 43
|
120.1 millimeters of mercury (mmHg)
Standard Deviation 12.08
|
118.3 millimeters of mercury (mmHg)
Standard Deviation 11.96
|
119.5 millimeters of mercury (mmHg)
Standard Deviation 12.28
|
122.1 millimeters of mercury (mmHg)
Standard Deviation 13.55
|
121.3 millimeters of mercury (mmHg)
Standard Deviation 12.10
|
|
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
SBP: Day 28, n=178, 139, 140, 42, 42
|
119.6 millimeters of mercury (mmHg)
Standard Deviation 12.76
|
120.5 millimeters of mercury (mmHg)
Standard Deviation 13.31
|
120.6 millimeters of mercury (mmHg)
Standard Deviation 12.71
|
120.4 millimeters of mercury (mmHg)
Standard Deviation 11.92
|
120.1 millimeters of mercury (mmHg)
Standard Deviation 10.58
|
|
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
DBP: Day 0, n=187, 140, 142, 42, 43
|
75.8 millimeters of mercury (mmHg)
Standard Deviation 8.26
|
74.6 millimeters of mercury (mmHg)
Standard Deviation 7.69
|
76.0 millimeters of mercury (mmHg)
Standard Deviation 8.03
|
77.5 millimeters of mercury (mmHg)
Standard Deviation 9.98
|
76.6 millimeters of mercury (mmHg)
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)Population: ITT Population. Only those participants available at the specified time points were analyzed.
Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Outcome measures
| Measure |
Placebo
n=187 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=140 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=142 Participants
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=42 Participants
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=43 Participants
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Day 0, n=187, 140, 142, 42, 43
|
77.0 beats per minute
Standard Deviation 9.53
|
76.4 beats per minute
Standard Deviation 9.27
|
77.6 beats per minute
Standard Deviation 8.71
|
74.5 beats per minute
Standard Deviation 9.22
|
75.8 beats per minute
Standard Deviation 8.12
|
|
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Day 28, n=178, 139, 140, 42, 42
|
76.6 beats per minute
Standard Deviation 8.79
|
76.9 beats per minute
Standard Deviation 9.32
|
77.7 beats per minute
Standard Deviation 9.47
|
74.7 beats per minute
Standard Deviation 7.96
|
74.6 beats per minute
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: From the first dose of the study medication up to Week 16/Early WithdrawalPopulation: ITT Population
Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which \>=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=43 Participants
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
|
5 participants
|
1 participants
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FF 200 µg OD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FF 100 µg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FP 200 µg OD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 100 µg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=187 participants at risk
Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 200 µg OD
n=140 participants at risk
Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FF 100 µg BID
n=142 participants at risk
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 200 µg OD
n=42 participants at risk
Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
FP 100 µg BID
n=43 participants at risk
Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/187 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
5.0%
7/140 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
4.9%
7/142 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/42 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
0.00%
0/43 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (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