Clinical Trial Results:
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
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Summary
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EudraCT number |
2010-019589-10 |
Trial protocol |
NL |
Global end of trial date |
27 Jul 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Apr 2016
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First version publication date |
12 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
HZA113091
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01147848 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford, Middlesex, United Kingdom,
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Public contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Sep 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jul 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective is to compare the efficacy of FF/GW642444 100/25 mcg,
administered once daily in the evening with FP/salmeterol 250/50 mcg administered
twice daily in subjects 12 years of age and older with persistent bronchial asthma over a 24 week treatment period.
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Protection of trial subjects |
The following steps were taken to protect trial subjects:
1). Only subjects meeting all of the inclusion criteria and none of the exclusion criteria were randomized to investigational medication.
2). All subjects enrolled into the study were provided rescue medication for use as necessary.
3) Both safety and efficacy parameters were also assessed by the investigator regularly in the clinic to minimise any potential risks to the patients.
4). The investigator or treating physician may unblind a subject’s treatment assignment in the case of an emergency, when knowledge of the study treatment is essential for the appropriate clinical management or welfare of the subject.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Jun 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 80
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Country: Number of subjects enrolled |
Argentina: 266
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Country: Number of subjects enrolled |
Chile: 220
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Country: Number of subjects enrolled |
Korea, Republic of: 199
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Country: Number of subjects enrolled |
Philippines: 348
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Country: Number of subjects enrolled |
United States: 451
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Worldwide total number of subjects |
1564
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EEA total number of subjects |
80
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
130
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Adults (18-64 years) |
1256
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From 65 to 84 years |
176
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85 years and over |
2
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Participants >=12 years of age with persistent asthma and Forced Expiratory Volume in one second (FEV1) of 40-85% of predicted normal and airway reversibility demonstrated by increase of >=12% in FEV1 and >=200ml following 2-4 inhalations of salbutamol/albuterol inhalation aerosol or equivalent dose of nebulised salbutamol/albuterol were eligible. | ||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Run-in Period
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
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Arms
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Arm title
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Fluticasone Propionate 250 µg BID | ||||||||||||||||||||||||||||||
Arm description |
Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms during the Run-In Period. This treatment group was not part of the primary or secondary end point reporting groups. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Fluticasone Propionate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms.
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Period 2
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Period 2 title |
Randomized Phase
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Is this the baseline period? |
Yes [1] | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fluticasone Furoate/Vilanterol 100/25 µg OD | ||||||||||||||||||||||||||||||
Arm description |
Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
FF/VI
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
100/25 mcg once daily via Ellipta Device
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Arm title
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Fluticasone Propionate/Salmeterol 250/50 µg BID | ||||||||||||||||||||||||||||||
Arm description |
Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks. | ||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
FP/Salmeterol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
250/50mcg twice daily via Diskus Inhaler
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| Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Baseline data are reported for participants starting the Randomized Phase (Period 2), which has been denoted as the baseline period. |
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| Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The number of participants enrolled in the trial worldwide (n=1564) represents the number of participants starting the Run-in Phase, not the number starting the Randomized Phase (the baseline period). |
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Baseline characteristics reporting groups
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Reporting group title |
Fluticasone Furoate/Vilanterol 100/25 µg OD
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Reporting group description |
Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluticasone Propionate/Salmeterol 250/50 µg BID
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Reporting group description |
Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fluticasone Propionate 250 µg BID
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Reporting group description |
Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms during the Run-In Period. This treatment group was not part of the primary or secondary end point reporting groups. | ||
Reporting group title |
Fluticasone Furoate/Vilanterol 100/25 µg OD
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Reporting group description |
Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks. | ||
Reporting group title |
Fluticasone Propionate/Salmeterol 250/50 µg BID
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Reporting group description |
Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks. | ||
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End point title |
Change from Baseline in weighted-mean 24 hour serial FEV1 on Day 168/Week 24 | ||||||||||||
End point description |
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment. ITT, Intent-to-Treat. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only those participants available at the indicated time point were assessed.
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End point type |
Primary
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End point timeframe |
Baseline and Day 168/Week 24
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| Notes [1] - ITT Population: participants randomized to treatment who received >=1 double-blind medication dose [2] - ITT Population: participants randomized to treatment who received >=1 double-blind medication dose |
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
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Comparison groups |
Fluticasone Furoate/Vilanterol 100/25 µg OD v Fluticasone Propionate/Salmeterol 250/50 µg BID
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Number of subjects included in analysis |
699
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.162 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.037
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.088 | ||||||||||||
upper limit |
0.015 | ||||||||||||
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End point title |
Serial FEV1 (0-24 hours) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . The pre-dose FEV1 assessment and the individual serial FEV1 assessments at Day 168/Week 24 at the indicated time points (pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 11 hours, 12 hours, 12.5 hours, 13 hours, 14 hours, 16 hours, 20 hours, 23 hours, and 24 hour s) were summarized.
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End point type |
Secondary
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End point timeframe |
Day 168
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| Notes [3] - ITT Population. Only those participants available at the indicated time points were assessed. [4] - ITT Population. Only those participants available at the indicated time points were assessed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of participants with the indicated time to onset of bronchodilator effect at Day 1 | |||||||||||||||||||||||||||||||||
End point description |
Time to onset of bronchodilator effect at Day 1 is defined as the actual time during the 4-hour serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) measurements that the participant first meets or exceeds a 12% and 200 mL increase over Baseline and was derived at Day 1 only. Time to onset was calculated over 0 to 4 hours (5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours) post-dose. Participants who never exceeded a 12% and 200 mL increase over Baseline were censored at the actual time of their last FEV1 measurement.
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End point type |
Secondary
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End point timeframe |
Baseline to Day 1
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| Notes [5] - ITT Population. Only those participants available at the indicated time points were assessed. [6] - ITT Population. Only those participants available at the indicated time points were assessed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in weighted mean serial FEV1 over 0-4 hours post first dose (at Randomization) | ||||||||||||
End point description |
The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 1 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
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End point type |
Secondary
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End point timeframe |
Baseline and Randomization
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| Notes [7] - ITT Population. Only those participants available at the indicated time point were assessed. [8] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in weighted mean serial FEV1 over 0-4 hours at Day 168 | ||||||||||||
End point description |
The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline and Day 168 was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
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End point type |
Secondary
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End point timeframe |
Baseline and Day 168
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| Notes [9] - ITT Population. Only those participants available at the indicated time point were assessed. [10] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 at 12 hours and at 24 hours | |||||||||||||||
End point description |
The number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated at 12-hours post-dose and at 24-hours post-dose on Day 168.
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End point type |
Secondary
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End point timeframe |
Baseline and Day 168
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| Notes [11] - ITT Population. Only those participants available at the indicated time points were assessed. [12] - ITT Population. Only those participants available at the indicated time points were assessed. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Change from Baseline in Trough FEV1 at Day 168 | ||||||||||||
End point description |
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Trough FEV1 is defined as the pre-dose measurement on Day 168/Week 24. Any missing data at Day 168/Week 24 was imputed using the last observation carried forward (LOCF). Baseline was the pre-dose measurement on Day 1. Change from Baseline was calculated as the pre-dose measurement on Day 168/Week 24 minus the Baseline value.
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End point type |
Secondary
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End point timeframe |
Baseline and Day 168
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| Notes [13] - ITT Population. Only those participants available at the indicated time point were assessed. [14] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Asthma Control Test (ACT) scores at Day 168 | ||||||||||||
End point description |
The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, "How much of the time did your asthma keep you from getting as much done at work, school or at home?", "How often have you had shortness of breath?", "How often did your asthma symptoms wake you up at night or earlier than usual in the morning?", "How often have you used your rescue inhaler or nebulizer medication (such as albuterol)?" and "How would you rate your asthma control"? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the Day 168 value minus the Baseline value.
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End point type |
Other pre-specified
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End point timeframe |
Baseline and Day 168
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| Notes [15] - ITT Population. Only those participants available at the indicated time point were assessed. [16] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of healthcare contacts related to asthma or the treatment of asthma from Baseline to Day 168 | |||||||||||||||||||||||||||||||||
End point description |
All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (to the general ward [GW] or the intensive care unit [ICU]) that were associated with asthma exacerbations were recorded.
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End point type |
Other pre-specified
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End point timeframe |
Baseline to Day 168
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| Notes [17] - ITT Population. Only those participants available at the indicated time point were assessed. [18] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total score for participants 12 years of age and older (AQLQ + 12) | ||||||||||||
End point description |
The AQLQ is a disease-specific, self-administered quality of life (QOL) questionnaire developed to evaluate the impact of asthma treatments on the QOL of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The response format consists of a 7-point scale: a value of 1 indicates "total impairment"; a value of 7 indicates "no impairment." The AQLQ total score is defined as the average of the scores from all 32 questions, provided at least 90% of the questions have been answered; thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Change from Baseline was calculated as the Day 168 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline total AQLQ score, country, sex, age, and treatment.
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End point type |
Other pre-specified
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End point timeframe |
Baseline and Day 168
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| Notes [19] - ITT Population. Only those participants available at the indicated time point were assessed. [20] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of participants with "No Problems" in the EQ-5D Descriptive System Dimensions at Day 168/Week 24 | |||||||||
End point description |
The EuroQol five-dimensions (EQ-5D) is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a three-point Likert scale (1=no problems, 2=some problems and 3=severe problems). Respondents are asked to choose one level that reflects their "own health state today" for each of the five dimensions.
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End point type |
Other pre-specified
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End point timeframe |
Day 168/Week 24
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| Notes [21] - ITT Population. Only those participants available at the indicated time point were assessed. [22] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change from Baseline in EQ-5D Visual Analog Scale (VAS) Score at Day 168 | ||||||||||||
End point description |
The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The second part is a 20 centimeter VAS that has endpoints labelled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively. Participants were asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS that best represents their own health on that day. Analysis was performed using ANCOVA with covariates of Baseline VAS score, country, sex, age, and treatment.
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End point type |
Other pre-specified
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End point timeframe |
Baseline and Day 168
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| Notes [23] - ITT Population. Only those participants available at the indicated time point were assessed. [24] - ITT Population. Only those participants available at the indicated time point were assessed. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study medication until Follow-up (up to 544 days).
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Adverse event reporting additional description |
All AEs and SAEs were followed until resolution, until the condition stabilized, until the event was otherwise explained, or until the participant was lost to follow-up.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
Fluticasone Furoate/Vilanterol 100/25 µg OD
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Reporting group description |
Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluticasone Propionate/Salmeterol 250/50 µg BID
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Reporting group description |
Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 3% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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31 Aug 2010 |
SCOPE: This amendment applies to all sites.
• To amend the pre-dose FEV1 assessment at randomisation (Visit 2) from 5 minutes to within 30 minutes of dosing;
• To insert a serum pregnancy test for females of child-bearing potential at early Withdrawal Visit on the Time and Events Table.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
