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A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01879410
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : August 15, 2014
Last Update Posted : November 8, 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 Pulmonary Disease, Chronic Obstructive
Interventions Drug: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI
Drug: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS
Drug: Placebo DISKUS
Drug: Placebo NDPI
Enrollment 700
Recruitment Details  
Pre-assignment Details A total of 700 participants representing the enrolled participants, were randomized to study treatment. Of these, 697 comprised the Intent-to-Treat Population (participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period).
Arm/Group Title UMEC/VI 62.5/25 µg FSC 250/50 µg
Hide Arm/Group Description Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg)) once daily (QD) in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI for 12 weeks. Participants received fluticasone propionate/salmeterol (FSC) 250/50 µg twice daily (BID) in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
Period Title: Overall Study
Started 350 350
Intent-to-Treat Population 349 348
Completed 326 312
Not Completed 24 38
Reason Not Completed
Adverse Event             9             14
Lack of Efficacy             4             6
Protocol Violation             1             7
Lost to Follow-up             2             1
Withdrawal by Subject             7             8
Randomised in Error             1             2
Arm/Group Title UMEC/VI 62.5/25 mcg FSC 250/50 mcg Total
Hide Arm/Group Description Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks. Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 349 348 697
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 349 participants 348 participants 697 participants
63.2  (8.57) 64.0  (8.53) 63.6  (8.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 348 participants 697 participants
Female
85
  24.4%
84
  24.1%
169
  24.2%
Male
264
  75.6%
264
  75.9%
528
  75.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 349 participants 348 participants 697 participants
African American/African Heritage 18 13 31
American Indian or Alaska Native 7 2 9
Asian 4 2 6
White 317 326 643
American Indian or Alaska Native & White 3 5 8
1.Primary Outcome
Title Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84
Hide Description FEV1 is a measure of lung function and is 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 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.
Time Frame Baseline and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received at least 1 dose of randomized study drug in the Treatment Period. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information and with >= post BL measurement were included in the analysis.
Arm/Group Title UMEC/VI 62.5/25 mcg FSC 250/50 mcg
Hide Arm/Group Description:
Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
Overall Number of Participants Analyzed 349 348
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.213  (0.0137) 0.112  (0.0139)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UMEC/VI 62.5/25 mcg, FSC 250/50 mcg
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.101
Confidence Interval (2-Sided) 95%
0.063 to 0.139
Estimation Comments Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.
2.Secondary Outcome
Title Change From Baseline(BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85
Hide Description FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the 2 assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, day by baseline and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.
Arm/Group Title UMEC/VI 62.5/25 mcg FSC 250/50 mcg
Hide Arm/Group Description:
Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
Overall Number of Participants Analyzed 349 348
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.185  (0.0138) 0.087  (0.0140)
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) collected from the start of study treatment up to the Follow-up Visit or premature withdrawal (up to Day 94)
Adverse Event Reporting Description SAEs and non-serious AEs are reported for members of the ITT Population,comprised of all randomized participants who received at least 1 dose of randomized study drug in the treatment period
 
Arm/Group Title UMEC/VI 62.5/25 mcg FSC 250/50 mcg
Hide Arm/Group Description Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks. Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
All-Cause Mortality
UMEC/VI 62.5/25 mcg FSC 250/50 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UMEC/VI 62.5/25 mcg FSC 250/50 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   11/349 (3.15%)   13/348 (3.74%) 
Cardiac disorders     
Myocardial infarction  1  1/349 (0.29%)  1/348 (0.29%) 
Atrial fibrillation  1  0/349 (0.00%)  1/348 (0.29%) 
Cardiac failure  1  1/349 (0.29%)  0/348 (0.00%) 
Infections and infestations     
Pneumonia  1  1/349 (0.29%)  4/348 (1.15%) 
Appendicitis  1  1/349 (0.29%)  0/348 (0.00%) 
Lobar pneumonia  1  1/349 (0.29%)  0/348 (0.00%) 
Perirectal abscess  1  1/349 (0.29%)  0/348 (0.00%) 
Respiratory tract infection viral  1  0/349 (0.00%)  1/348 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  0/349 (0.00%)  1/348 (0.29%) 
Lung adenocarcinoma  1  1/349 (0.29%)  0/348 (0.00%) 
Small cell lung cancer  1  0/349 (0.00%)  1/348 (0.29%) 
Psychiatric disorders     
Alcohol abuse  1  1/349 (0.29%)  0/348 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  4/349 (1.15%)  4/348 (1.15%) 
Pleurisy  1  0/349 (0.00%)  1/348 (0.29%) 
Pneumothorax spontaneous  1  0/349 (0.00%)  1/348 (0.29%) 
Respiratory failure  1  0/349 (0.00%)  1/348 (0.29%) 
Vascular disorders     
Peripheral artery thrombosis  1  1/349 (0.29%)  0/348 (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%
UMEC/VI 62.5/25 mcg FSC 250/50 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   36/349 (10.32%)   28/348 (8.05%) 
Infections and infestations     
Nasopharyngitis  1  14/349 (4.01%)  6/348 (1.72%) 
Nervous system disorders     
Headache  1  24/349 (6.88%)  23/348 (6.61%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01879410     History of Changes
Other Study ID Numbers: 114951
First Submitted: June 13, 2013
First Posted: June 17, 2013
Results First Submitted: July 24, 2014
Results First Posted: August 15, 2014
Last Update Posted: November 8, 2017