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Trial record 66 of 318 for:    FLUTICASONE AND SALMETEROL

HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

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ClinicalTrials.gov Identifier: NCT01147848
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : September 5, 2013
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Fluticasone furoate/Vilanterol Inhalation Powder
Drug: Fluticasone propionate/salmeterol Inhalation Powder
Drug: Placebo (1)
Drug: Placebo (2)
Enrollment 810
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluticasone Propionate 250 µg BID Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/Group Description Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms. 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. 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.
Period Title: Run-in Period
Started 1564 0 0
Completed 806 0 0
Not Completed 758 0 0
Reason Not Completed
Screen Failure             623             0             0
Run-in Failure             135             0             0
Period Title: Randomized Phase
Started 0 403 403
Completed 0 358 357
Not Completed 0 45 46
Reason Not Completed
Adverse Event             0             6             8
Lack of Efficacy             0             20             11
Protocol Violation             0             7             10
Lost to Follow-up             0             5             7
Physician Decision             0             0             1
Withdrawal by Subject             0             7             9
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID Total
Hide Arm/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. 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. Total of all reporting groups
Overall Number of Baseline Participants 403 403 806
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 403 participants 403 participants 806 participants
43.8  (15.86) 41.9  (16.90) 42.8  (16.41)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 806 participants
Female
244
  60.5%
245
  60.8%
489
  60.7%
Male
159
  39.5%
158
  39.2%
317
  39.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 806 participants
African American/African Heritage 36 43 79
Asian - Central/South Asian Heritage 1 0 1
Asian - East Asian Heritage 40 46 86
Asian - Japanese Heritage 1 0 1
Asian - South East Asian Heritage 81 79 160
Asian - Mixed Race 1 0 1
Native Hawaiian or Other Pacific Islander 1 1 2
White - Arabic/North African Heritage 1 0 1
White - White/Caucasian/European Heritage 241 232 473
Mixed Race 0 2 2
1.Primary Outcome
Title Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24
Hide 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.
Time Frame Baseline and Day 168/Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. 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.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 352 347
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.341  (0.0184) 0.377  (0.0185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone Furoate/Vilanterol 100/25 µg OD, Fluticasone Propionate/Salmeterol 250/50 µg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.037
Confidence Interval (2-Sided) 95%
-0.088 to 0.015
Estimation Comments Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
2.Secondary Outcome
Title Serial FEV1 (0-24 Hours)
Hide 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.
Time Frame Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 359 354
Mean (Standard Deviation)
Unit of Measure: Liters
Pre-dose, n=359,353 0.304  (0.3575) 0.323  (0.4289)
5 minutes, n=356, 344 0.320  (0.3573) 0.339  (0.4146)
15 minutes, n=355, 347 0.323  (0.3565) 0.354  (0.4054)
30 minutes, n=357, 351 0.339  (0.3614) 0.366  (0.4184)
1 hour, n=358, 353 0.344  (0.3760) 0.390  (0.4227)
2 hours, n=359, 353 0.362  (0.3749) 0.409  (0.4204)
3 hours, n=357, 353 0.373  (0.3764) 0.419  (0.4173)
4 hours, n=357, 354 0.356  (0.3695) 0.417  (0.4254)
11 hours, n=359, 347 0.305  (0.3761) 0.319  (0.4099)
12 hours, n=356, 354 0.330  (0.3691) 0.338  (0.4142)
12.5 hours, n=357, 352 0.330  (0.3682) 0.380  (0.4117)
13 hours, n=354, 354 0.343  (0.3602) 0.396  (0.4139)
14 hours, n=356, 353 0.357  (0.3643) 0.426  (0.4201)
16 hours, n=354, 350 0.351  (0.3672) 0.419  (0.4152)
20 hours, n=355, 352 0.321  (0.3757) 0.376  (0.4150)
23 hours, n=354, 353 0.310  (0.3814) 0.344  (0.4141)
24 hours, n=354, 354 0.304  (0.3725) 0.340  (0.4032)
3.Secondary Outcome
Title Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1
Hide 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.
Time Frame Baseline to Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 400 401
Measure Type: Number
Unit of Measure: participants
5 minutes 100 85
15 minutes 41 51
30 minutes 40 55
1 hour 32 39
2 hours 19 29
3 hours 17 12
4 hours 11 12
Censored 140 118
4.Secondary Outcome
Title Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)
Hide 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.
Time Frame Baseline and Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title FFluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 398 398
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.316  (0.0149) 0.346  (0.0149)
5.Secondary Outcome
Title Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168
Hide 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.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 356 347
Mean (Standard Deviation)
Unit of Measure: Liters
0.360  (0.0184) 0.394  (0.0186)
6.Secondary Outcome
Title Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1
Hide 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.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 356 354
Measure Type: Number
Unit of Measure: participants
12 hours post-dose, n=356,354 199 178
24 hours post-dose, n=354, 354 181 176
7.Secondary Outcome
Title Change From Baseline in Trough FEV1 at Day 168
Hide 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.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 397 389
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.281  (0.0191) 0.300  (0.0193)
8.Other Pre-specified Outcome
Title Baseline FEV1 by Completion Status
Hide Description Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 401 401
Mean (Standard Deviation)
Unit of Measure: Liters
All Participants, n=401, 401 2.011  (0.6389) 2.048  (0.6246)
Completers, n=359, 355 2.013  (0.6530) 2.043  (0.6378)
Withdrawals, n=42, 46 1.996  (0.5081) 2.091  (0.5145)
9.Other Pre-specified Outcome
Title Change From Baseline in Asthma Control Test (ACT) Scores at Day 168
Hide 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.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed. Analysis was performed using ANCOVA with covariates of Baseline total ACT score, country, sex, age, and treatment.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 354 348
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
2.3  (0.16) 2.0  (0.16)
10.Other Pre-specified Outcome
Title Number of Healthcare Contacts Related to Asthma or the Treatment of Asthma From Baseline to Day 168
Hide 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.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 403 403
Mean (Standard Deviation)
Unit of Measure: visits per participant
Number of Home Visits during the Day 0.0  (0.0) 0.0  (0.05)
Number of Home Visits during the Night 0.0  (0.0) 0.0  (0.0)
Number of Physician Office/Practice Visits 0.0  (0.29) 0.0  (0.18)
Number of Urgent Care/Outpatient Clinic Visits 0.0  (0.05) 0.0  (0.05)
Number of Emergency Room Visits 0.0  (0.15) 0.0  (0.14)
Number of Inpatient Hospitalization (ICU) Days 0.0  (0.00) 0.0  (0.0)
Number of Inpatient Hospitalization (GW) Days 0.0  (0.20) 0.0  (0.39)
11.Other Pre-specified Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score for Participants 12 Years of Age and Older (AQLQ + 12)
Hide 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.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 342 335
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.46  (0.043) 0.37  (0.043)
12.Other Pre-specified Outcome
Title Percentage of Participants With "No Problems" in the EQ-5D Descriptive System Dimensions at Day 168/Week 24
Hide 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). 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.
Time Frame Day 168/Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 403 403
Measure Type: Number
Unit of Measure: percentage of participants
Mobility 86 84
Self care 98 98
Usual activities 86 82
Pain/Discomfort 70 66
Anxiety/Depression 78 81
13.Other Pre-specified Outcome
Title Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at Day 168
Hide 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.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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.
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.
Overall Number of Participants Analyzed 343 349
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
5.5  (0.60) 4.1  (0.60)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study medication until Follow-up (up to 544 days).
Adverse Event Reporting 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.
 
Arm/Group Title Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Hide Arm/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. 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.
All-Cause Mortality
Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   4/403 (0.99%)   5/403 (1.24%) 
Cardiac disorders     
Myocardial ischaemia  1  1/403 (0.25%)  0/403 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/403 (0.25%)  0/403 (0.00%) 
Infections and infestations     
Pneumonia  1  0/403 (0.00%)  1/403 (0.25%) 
Upper respiratory tract infection  1  1/403 (0.25%)  0/403 (0.00%) 
Urinary tract infection  1  0/403 (0.00%)  1/403 (0.25%) 
Injury, poisoning and procedural complications     
Carbon monoxide poisoning  1  0/403 (0.00%)  1/403 (0.25%) 
Psychiatric disorders     
Disorientation  1  0/403 (0.00%)  1/403 (0.25%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/403 (0.25%)  2/403 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Fluticasone Furoate/Vilanterol 100/25 µg OD Fluticasone Propionate/Salmeterol 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   110/403 (27.30%)   106/403 (26.30%) 
General disorders     
Pyrexia  1  13/403 (3.23%)  5/403 (1.24%) 
Infections and infestations     
Nasopharyngitis  1  46/403 (11.41%)  46/403 (11.41%) 
Upper respiratory tract infection  1  25/403 (6.20%)  16/403 (3.97%) 
Nervous system disorders     
Headache  1  34/403 (8.44%)  41/403 (10.17%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  15/403 (3.72%)  13/403 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01147848     History of Changes
Other Study ID Numbers: 113091
First Submitted: May 27, 2010
First Posted: June 22, 2010
Results First Submitted: June 6, 2013
Results First Posted: September 5, 2013
Last Update Posted: January 18, 2017