Trial Outcomes & Findings for A Study to Compare the Efficacy and Safety of Fluticasone Furoate (FF) 100 mcg Once Daily With Fluticasone Propionate (FP) 250 mcg Twice Daily (BD) and FP 100 mcg BD in Well-controlled Asthmatic Japanese Subjects (NCT NCT02094937)
NCT ID: NCT02094937
Last Updated: 2017-05-25
Results Overview
Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity \[morning\] or to 4-symptoms so severe that par could not sleep at all \[nightly\]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF \<80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) \< 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced.
COMPLETED
PHASE3
430 participants
From Week 9 to Week 20
2017-05-25
Participant Flow
A total of 551 participants were screened, 490 entered into the run-in period, 430 entered into the open label treatment period 1(Period 1) and 371 were further randomized to treatment Period 2 (Period 2). Note that 1 subject was randomized incorrectly even though the subject failed at randomization.
Eligible participants entered a 4 week run-in period followed by an 8 week open label treatment period. Participants whose asthma was well controlled at visit 5 (end of Period 1) were randomized in a 1:1:1 ratio to a double blind study period of 12 weeks. They were informed to avoid Salbutamol inhaler within 6 hours at each visit.
Participant milestones
| Measure |
FF/VI 100/25 mcg OD
Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
|
FF 100 mcg OD
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|---|
|
8 Weeks in Period 1
STARTED
|
430
|
0
|
0
|
0
|
|
8 Weeks in Period 1
COMPLETED
|
370
|
0
|
0
|
0
|
|
8 Weeks in Period 1
NOT COMPLETED
|
60
|
0
|
0
|
0
|
|
12 Weeks in Period 2
STARTED
|
0
|
123
|
124
|
124
|
|
12 Weeks in Period 2
COMPLETED
|
0
|
112
|
112
|
112
|
|
12 Weeks in Period 2
NOT COMPLETED
|
0
|
11
|
12
|
12
|
Reasons for withdrawal
| Measure |
FF/VI 100/25 mcg OD
Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
|
FF 100 mcg OD
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|---|
|
8 Weeks in Period 1
Adverse Event
|
9
|
0
|
0
|
0
|
|
8 Weeks in Period 1
Lack of Efficacy
|
3
|
0
|
0
|
0
|
|
8 Weeks in Period 1
Protocol Violation
|
2
|
0
|
0
|
0
|
|
8 Weeks in Period 1
Protocol defined stopping criteria
|
41
|
0
|
0
|
0
|
|
8 Weeks in Period 1
Physician Decision
|
1
|
0
|
0
|
0
|
|
8 Weeks in Period 1
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
|
12 Weeks in Period 2
Adverse Event
|
0
|
2
|
4
|
1
|
|
12 Weeks in Period 2
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
12 Weeks in Period 2
Protocol defined stopping criteria
|
0
|
5
|
6
|
11
|
|
12 Weeks in Period 2
Withdrawal by Subject
|
0
|
2
|
2
|
0
|
|
12 Weeks in Period 2
Randomized incorrectly
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Compare the Efficacy and Safety of Fluticasone Furoate (FF) 100 mcg Once Daily With Fluticasone Propionate (FP) 250 mcg Twice Daily (BD) and FP 100 mcg BD in Well-controlled Asthmatic Japanese Subjects
Baseline characteristics by cohort
| Measure |
Period 1- FF/VI 100/25 mcg OD
n=430 Participants
Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
|
|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 14.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
261 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese Heritage
|
430 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Week 9 to Week 20Population: Intent-to-treat (ITT) population defined as participants randomized to treatment and who received at least one dose of randomized study medication in Period 2.
Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity \[morning\] or to 4-symptoms so severe that par could not sleep at all \[nightly\]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF \<80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) \< 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced.
Outcome measures
| Measure |
FF 100 mcg OD
n=123 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=124 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=124 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Percentage of Participants (Par) Withdrawn From the Study Due to "Poorly-controlled Asthma" During Period 2
|
4.9 Percentage of Participants
Interval 1.81 to 10.32
|
7.3 Percentage of Participants
Interval 3.37 to 13.33
|
8.1 Percentage of Participants
Interval 3.94 to 14.33
|
PRIMARY outcome
Timeframe: Week 20Population: ITT population. Participants who withdrew prior to Visit 11 for the reasons other than exacerbation were excluded.
Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity\[morning\] or to 4-symptoms so severe that par could not sleep at all\[nightly\]. "Well-controlled asthma" was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. "Well-controlled asthma" at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Percentage of participants were calculated as the number of participants with "well-controlled asthma" divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group.
Outcome measures
| Measure |
FF 100 mcg OD
n=114 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=119 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=118 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2
|
89.5 Percentage of Participants
Interval 82.33 to 94.44
|
78.2 Percentage of Participants
Interval 69.65 to 85.2
|
83.1 Percentage of Participants
Interval 75.04 to 89.33
|
SECONDARY outcome
Timeframe: Week 20Population: ITT population. Number of participants available for the last post-baseline value during Period 2 were used for analysis.
FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented \[least square mean (LSM)\].
Outcome measures
| Measure |
FF 100 mcg OD
n=122 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=124 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=124 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2
|
-0.129 Liter
Standard Error 0.0158
|
-0.135 Liter
Standard Error 0.0154
|
-0.105 Liter
Standard Error 0.0155
|
SECONDARY outcome
Timeframe: From Week 9 to Week 20Population: ITT population. Only those participants available at specified timepoints were analyzed
Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented \[least square mean (LSM)\].
Outcome measures
| Measure |
FF 100 mcg OD
n=123 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=124 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=124 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2
PEF at AM, n=122, 124, 124
|
-18.2 Liter per minute (L/min)
Standard Error 2.09
|
-21.3 Liter per minute (L/min)
Standard Error 2.06
|
-18.1 Liter per minute (L/min)
Standard Error 2.06
|
|
Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2
PEF at PM, n=122, 124, 124
|
-19.2 Liter per minute (L/min)
Standard Error 2.04
|
-19.3 Liter per minute (L/min)
Standard Error 2.01
|
-18.7 Liter per minute (L/min)
Standard Error 2.02
|
SECONDARY outcome
Timeframe: From Week 9 to Week 20Population: ITT population. Only those participants available at specified time point were analyzed
Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity \[morning\] or to 4-symptoms so severe that participants could not sleep at all \[nightly\]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented \[least square mean (LSM)\].
Outcome measures
| Measure |
FF 100 mcg OD
n=122 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=124 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=124 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2
|
-1.0 Percentage of symptom-free 24-h period
Standard Error 0.654
|
-1.3 Percentage of symptom-free 24-h period
Standard Error 0.653
|
-1.8 Percentage of symptom-free 24-h period
Standard Error 0.652
|
SECONDARY outcome
Timeframe: From Week 9 to Week 20Population: ITT population. Only those participants available at specified time point were analyzed
The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented \[least square mean (LSM)\].
Outcome measures
| Measure |
FF 100 mcg OD
n=122 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=124 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=124 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2
|
-0.9 Percentage of rescue-free 24-hr periods
Standard Error 0.554
|
-2.1 Percentage of rescue-free 24-hr periods
Standard Error 0.553
|
-1.2 Percentage of rescue-free 24-hr periods
Standard Error 0.552
|
SECONDARY outcome
Timeframe: Week 20Population: ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.
The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented \[least square mean(LSM)\].
Outcome measures
| Measure |
FF 100 mcg OD
n=122 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=124 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=124 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2
|
-0.3 Score on scale
Standard Error 0.225
|
-0.6 Score on scale
Standard Error 0.224
|
-0.8 Score on scale
Standard Error 0.223
|
SECONDARY outcome
Timeframe: Week 20Population: ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.
Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score \>=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group.
Outcome measures
| Measure |
FF 100 mcg OD
n=112 Participants
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD
n=114 Participants
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD
n=114 Participants
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|
|
Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20)
|
99.1 Percentage of participants
Interval 95.13 to 99.98
|
97.4 Percentage of participants
Interval 92.5 to 99.45
|
96.5 Percentage of participants
Interval 91.26 to 99.04
|
Adverse Events
FF/VI 100/25 mcg OD Period 1
FF 100 mcg OD Period 2
FP 100 mcg BD Period 2
FP 250 mcg BD Period 2
Serious adverse events
| Measure |
FF/VI 100/25 mcg OD Period 1
n=430 participants at risk
Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
|
FF 100 mcg OD Period 2
n=123 participants at risk
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD Period 2
n=124 participants at risk
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD Period 2
n=124 participants at risk
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/430 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
0.00%
0/123 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
0.00%
0/124 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
0.81%
1/124 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.00%
0/430 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
0.81%
1/123 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
0.00%
0/124 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
0.00%
0/124 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
Other adverse events
| Measure |
FF/VI 100/25 mcg OD Period 1
n=430 participants at risk
Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
|
FF 100 mcg OD Period 2
n=123 participants at risk
Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 100 mcg BD Period 2
n=124 participants at risk
Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
FP 250 mcg BD Period 2
n=124 participants at risk
Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.6%
67/430 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
17.9%
22/123 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
17.7%
22/124 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
22.6%
28/124 • Adverse events and Serious adverse events were collected from start of treatment Period 1 (Week 0) to Period 2 (Week 20).
Serious adverse events (AEs) and non-serious AEs were reported for participants in open label population which composed of participants receiving at least one dose of study medication in the Period 1 and the Intent-to-Treat (ITT) Population in Period 2.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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