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A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01053988
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : August 15, 2013
Last Update Posted : July 12, 2018
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 Pulmonary Disease, Chronic Obstructive
Interventions Drug: FF/GW642444 Inhalation Powder
Drug: FF Inhalation Powder
Drug: GW642444 Inhalation Powder
Drug: Placebo
Enrollment 1031
Recruitment Details  
Pre-assignment Details Eligible participants (par.) completed a 2-week single-blind (placebo) Run-in Period (RIP) to assess Baseline rescue use, symptoms, disease stability. Par. were then randomized to a 24-week Treatment Period. A total of 1804 par. were screened, 1390 entered the RIP, of whom 1031 were randomized, 1030 received at least one dose of study medication.
Arm/Group Title Placebo Run-in Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description Participants received placebo once daily (OD) in the morning for 2 weeks. Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks. Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks. Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks. Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks. Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Period Title: 2-week, Single-blind Run-In Period
Started 1390 0 0 0 0 0
Completed 1030 0 0 0 0 0
Not Completed 360 0 0 0 0 0
Reason Not Completed
Did Not Meet Continuation Criteria             220             0             0             0             0             0
Study Closed/Terminated             98             0             0             0             0             0
Withdrawal by Subject             30             0             0             0             0             0
Adverse Event             6             0             0             0             0             0
Physician Decision             5             0             0             0             0             0
Lost to Follow-up             1             0             0             0             0             0
Period Title: 24-week, Double-blind Treatment Period
Started 0 207 206 205 206 206
Completed 0 138 145 142 147 151
Not Completed 0 69 61 63 59 55
Reason Not Completed
Adverse Event             0             15             23             24             17             14
Lack of Efficacy-No Sub-Reason             0             3             2             2             3             0
Lack of Efficacy-Sub-Reason Exacerbation             0             17             16             13             9             12
Protocol Violation             0             3             4             2             1             4
Met Protocol-Defined Stopping Criteria             0             11             5             8             13             9
Lost to Follow-up             0             4             0             2             1             3
Physician Decision             0             5             2             5             5             4
Withdrawal by Subject             0             11             9             7             10             9
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD Total
Hide Arm/Group Description Participants received placebo OD in the morning from the DPI for 24 weeks. Participants received FF 100 µg OD in the morning from the DPI for 24 weeks. Participants received VI 25 µg OD in the morning from the DPI for 24 weeks. Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks. Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 207 206 205 206 206 1030
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 206 participants 205 participants 206 participants 206 participants 1030 participants
62.1  (8.80) 62.7  (9.47) 63.4  (9.58) 62.8  (9.13) 62.3  (8.49) 62.7  (9.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 206 participants 205 participants 206 participants 206 participants 1030 participants
Female
66
  31.9%
74
  35.9%
65
  31.7%
71
  34.5%
69
  33.5%
345
  33.5%
Male
141
  68.1%
132
  64.1%
140
  68.3%
135
  65.5%
137
  66.5%
685
  66.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 206 participants 205 participants 206 participants 206 participants 1030 participants
African American/African Heritage (HER) 7 3 7 6 9 32
American Indian or Alaska Native 1 0 0 1 1 3
Central/South Asian HER 0 0 1 0 0 1
Japanese/East Asian HER/South East Asian HER 44 64 56 43 46 253
White 155 139 141 156 150 741
1.Primary Outcome
Title Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168
Hide Description Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Time Frame Baseline (BL) to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description:
Participants received placebo OD in the morning from the DPI for 24 weeks.
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Overall Number of Participants Analyzed 139 145 144 146 151
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.026  (0.0184) 0.080  (0.0182) 0.129  (0.0182) 0.218  (0.0181) 0.200  (0.0179)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.053
Confidence Interval (2-Sided) 95%
0.003 to 0.104
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VI 25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.103
Confidence Interval (2-Sided) 95%
0.052 to 0.153
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, FF/VI 50/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.192
Confidence Interval (2-Sided) 95%
0.141 to 0.243
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, FF/VI 100/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.173
Confidence Interval (2-Sided) 95%
0.123 to 0.224
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FF 100 µg OD, FF/VI 100/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.120
Confidence Interval (2-Sided) 95%
0.070 to 0.170
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VI 25 µg OD, FF/VI 50/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.090
Confidence Interval (2-Sided) 95%
0.039 to 0.140
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection VI 25 µg OD, FF/VI 100/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.071
Confidence Interval (2-Sided) 95%
0.021 to 0.121
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169
Hide Description Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description:
Participants received placebo OD in the morning from the DPI for 24 weeks.
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Overall Number of Participants Analyzed 136 143 143 144 146
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.037  (0.0199) 0.070  (0.0196) 0.103  (0.0196) 0.166  (0.0196) 0.151  (0.0194)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.033
Confidence Interval (2-Sided) 95%
-0.022 to 0.088
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VI 25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.067
Confidence Interval (2-Sided) 95%
0.012 to 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, FF/VI 50/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.129
Confidence Interval (2-Sided) 95%
0.074 to 0.184
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, FF/VI 100/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.115
Confidence Interval (2-Sided) 95%
0.060 to 0.169
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FF 100 µg OD, FF/VI 100/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.082
Confidence Interval (2-Sided) 95%
0.028 to 0.136
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VI 25 µg OD, FF/VI 50/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.062
Confidence Interval (2-Sided) 95%
0.008 to 0.117
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection VI 25 µg OD, FF/VI 100/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.048
Confidence Interval (2-Sided) 95%
-0.006 to 0.102
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168
Hide Description Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description:
Participants received placebo OD in the morning from the DPI for 24 weeks.
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Overall Number of Participants Analyzed 135 143 140 145 147
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.23  (0.088) 0.29  (0.086) 0.37  (0.086) 0.42  (0.085) 0.53  (0.085)
4.Secondary Outcome
Title Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.
Time Frame Baseline and Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description:
Participants received placebo OD in the morning from the DPI for 24 weeks.
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Overall Number of Participants Analyzed 207 206 205 205 206
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.106  (0.0098) 0.118  (0.0099) 0.247  (0.0099) 0.253  (0.0099) 0.245  (0.0099)
5.Secondary Outcome
Title Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.
Time Frame Baseline and Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description:
Participants received placebo OD in the morning from the DPI for 24 weeks.
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Overall Number of Participants Analyzed 207 206 205 205 206
Median (Full Range)
Unit of Measure: Minutes
NA [1] 
(5 to 240)
NA [1] 
(5 to 240)
16
(5 to 240)
17
(5 to 240)
17
(5 to 240)
[1]
> 50% of participants were censored; therefore, the median could not be calculated.
Time Frame On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24).
Adverse Event Reporting Description An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication
 
Arm/Group Title Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Hide Arm/Group Description Participants received placebo OD in the morning from the DPI for 24 weeks. Participants received FF 100 µg OD in the morning from the DPI for 24 weeks. Participants received VI 25 µg OD in the morning from the DPI for 24 weeks. Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks. Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
All-Cause Mortality
Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/207 (5.31%)   16/206 (7.77%)   15/205 (7.32%)   6/206 (2.91%)   11/206 (5.34%) 
Cardiac disorders           
Myocardial infarction  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  1/206 (0.49%) 
Angina unstable  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Coronary artery disease  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Supraventricular extrasystoles  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Ear and labyrinth disorders           
Deafness neurosensory  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Gastrointestinal disorders           
Colitis  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Gastrointestinal haemorrhage  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
General disorders           
Chest discomfort  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Sudden cardiac death  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Hepatobiliary disorders           
Cholangitis  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  1/206 (0.49%) 
Infections and infestations           
Pneumonia  1  1/207 (0.48%)  2/206 (0.97%)  3/205 (1.46%)  1/206 (0.49%)  1/206 (0.49%) 
Gastroenteritis  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  1/206 (0.49%) 
Pneumonia pneumococcal  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Injury, poisoning and procedural complications           
Alcohol poisoning  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Fractured coccyx  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Multiple fractures  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Multiple injuries  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Radius fracture  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Road traffic accident  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Subdural haematoma  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  1/206 (0.49%) 
Transplant failure  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Vascular pseudoaneurysm  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  1/207 (0.48%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Musculoskeletal and connective tissue disorders           
Cervical spinal stenosis  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Intervertebral disc disorder  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Prostate cancer  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  1/206 (0.49%) 
Glottis carcinoma  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Lip and/or oral cavity cancer  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Nasopharyngeal cancer stage IV  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Small cell lung cancer stage unspecified  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Transitional cell carcinoma  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Nervous system disorders           
Carotid artery stenosis  1  0/207 (0.00%)  2/206 (0.97%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Ischaemic stroke  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  2/206 (0.97%) 
Cerebral haemorrhage  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Hypertonia  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Intracranial aneurysm  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Myasthenia gravis  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
Subarachnoid haemorrhage  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Transient ischaemic attack  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Renal and urinary disorders           
Nephrolithiasis  1  0/207 (0.00%)  0/206 (0.00%)  1/205 (0.49%)  0/206 (0.00%)  0/206 (0.00%) 
Renal failure acute  1  1/207 (0.48%)  0/206 (0.00%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  3/207 (1.45%)  2/206 (0.97%)  6/205 (2.93%)  0/206 (0.00%)  4/206 (1.94%) 
Vascular disorders           
Arteriosclerosis  1  0/207 (0.00%)  1/206 (0.49%)  0/205 (0.00%)  0/206 (0.00%)  0/206 (0.00%) 
Peripheral arterial occlusive disease  1  0/207 (0.00%)  0/206 (0.00%)  0/205 (0.00%)  1/206 (0.49%)  0/206 (0.00%) 
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%
Placebo FF 100 µg OD VI 25 µg OD FF/VI 50/25 µg OD FF/VI 100/25 µg OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/207 (17.87%)   59/206 (28.64%)   53/205 (25.85%)   52/206 (25.24%)   63/206 (30.58%) 
Infections and infestations           
Nasopharyngitis  1  14/207 (6.76%)  18/206 (8.74%)  22/205 (10.73%)  14/206 (6.80%)  22/206 (10.68%) 
Upper respiratory tract infection  1  8/207 (3.86%)  13/206 (6.31%)  11/205 (5.37%)  16/206 (7.77%)  21/206 (10.19%) 
Oropharyngeal candidiasis  1  2/207 (0.97%)  4/206 (1.94%)  2/205 (0.98%)  10/206 (4.85%)  6/206 (2.91%) 
Oral candidiasis  1  1/207 (0.48%)  2/206 (0.97%)  3/205 (1.46%)  8/206 (3.88%)  4/206 (1.94%) 
Sinusitis  1  2/207 (0.97%)  7/206 (3.40%)  3/205 (1.46%)  1/206 (0.49%)  4/206 (1.94%) 
Lower respiratory tract infection  1  7/207 (3.38%)  1/206 (0.49%)  4/205 (1.95%)  3/206 (1.46%)  1/206 (0.49%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  4/207 (1.93%)  5/206 (2.43%)  7/205 (3.41%)  7/206 (3.40%)  6/206 (2.91%) 
Arthralgia  1  2/207 (0.97%)  7/206 (3.40%)  2/205 (0.98%)  1/206 (0.49%)  2/206 (0.97%) 
Nervous system disorders           
Headache  1  5/207 (2.42%)  17/206 (8.25%)  16/205 (7.80%)  12/206 (5.83%)  18/206 (8.74%) 
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01053988     History of Changes
Other Study ID Numbers: 112206
First Submitted: January 14, 2010
First Posted: January 22, 2010
Results First Submitted: June 12, 2013
Results First Posted: August 15, 2013
Last Update Posted: July 12, 2018