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Trial record 62 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT01817764
Recruitment Status : Completed
First Posted : March 25, 2013
Results First Posted : May 29, 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: Umeclidinium/vilanterol
Drug: Fluticasone propionate/salmeterol
Drug: Placebo
Enrollment 707
Recruitment Details  
Pre-assignment Details A total of 707 participants, representing the enrolled participants, were randomized to study treatment. Of these, 706 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 QD FSC 250/50 µg BID
Hide Arm/Group Description Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI. Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
Period Title: Overall Study
Started 353 353
Completed 319 315
Not Completed 34 38
Reason Not Completed
Adverse Event             7             10
Lack of Efficacy             9             7
Protocol Violation             7             5
Lost to Follow-up             1             4
Withdrawal by Subject             10             12
Arm/Group Title UMEC/VI 62.5/25 µg QD FSC 250/50 µg BID Total
Hide Arm/Group Description Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI. Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI. Total of all reporting groups
Overall Number of Baseline Participants 353 353 706
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 353 participants 353 participants 706 participants
62.5  (9.05) 63.0  (8.91) 62.8  (8.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 353 participants 706 participants
Female
100
  28.3%
109
  30.9%
209
  29.6%
Male
253
  71.7%
244
  69.1%
497
  70.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 353 participants 706 participants
African American/African Heritage 4 3 7
American Indian or Alaska Native 5 5 10
Asian - East Asian Heritage 1 1 2
Asian - Japanese Heritage 2 1 3
White - Arabic/North African Heritage 0 1 1
White - White/Caucasian/European 341 342 683
1.Primary Outcome
Title Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment 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. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.
Time Frame Baseline and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose of randomized study medication in the treatment period. Only par. with analyzable data at the indicated time point were assessed, but all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.
Arm/Group Title UMEC/VI 62.5/25 µg QD FSC 250/50 µg BID
Hide Arm/Group Description:
Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
Overall Number of Participants Analyzed 315 310
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.165  (0.0130) 0.091  (0.0131)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UMEC/VI 62.5/25 µg QD, FSC 250/50 µg BID
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 (Net)
Estimated Value 0.074
Confidence Interval (2-Sided) 95%
0.038 to 0.110
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Trough FEV1 on Day 85
Hide Description Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing/11 and 12 hours after evening dosing on Day 84. Change from Baseline is calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, day, and day by Baseline and day by treatment interactions.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
Arm/Group Title UMEC/VI 62.5/25 µg QD FSC 250/50 µg BID
Hide Arm/Group Description:
Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
Overall Number of Participants Analyzed 317 312
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.154  (0.0133) 0.072  (0.0134)
Time Frame On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up contact (up to 13 weeks).
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the treatment period.
 
Arm/Group Title UMEC/VI 62.5/25 µg QD FSC 250/50 µg BID
Hide Arm/Group Description Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI. Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
All-Cause Mortality
UMEC/VI 62.5/25 µg QD FSC 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UMEC/VI 62.5/25 µg QD FSC 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   6/353 (1.70%)   10/353 (2.83%) 
Cardiac disorders     
Myocardial infarction  1  0/353 (0.00%)  1/353 (0.28%) 
Gastrointestinal disorders     
Upper gastrointestinal haemorrhage  1  1/353 (0.28%)  0/353 (0.00%) 
Infections and infestations     
Pneumonia  1  0/353 (0.00%)  3/353 (0.85%) 
Bronchitis  1  0/353 (0.00%)  1/353 (0.28%) 
Burn infection  1  0/353 (0.00%)  1/353 (0.28%) 
Gastroenteritis viral  1  1/353 (0.28%)  0/353 (0.00%) 
Infective exacerbation of chronic obstructive airways diseas  1  0/353 (0.00%)  1/353 (0.28%) 
Injury, poisoning and procedural complications     
Head injury  1  1/353 (0.28%)  0/353 (0.00%) 
Subdural haematoma  1  1/353 (0.28%)  0/353 (0.00%) 
Thermal burn  1  0/353 (0.00%)  1/353 (0.28%) 
Investigations     
Alanine aminotransferase increased  1  0/353 (0.00%)  1/353 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Non-small cell lung cancer  1  0/353 (0.00%)  1/353 (0.28%) 
Ovarian cancer  1  1/353 (0.28%)  0/353 (0.00%) 
Nervous system disorders     
Ischaemic stroke  1  0/353 (0.00%)  2/353 (0.57%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/353 (0.28%)  3/353 (0.85%) 
Obstructive airways disorder  1  1/353 (0.28%)  0/353 (0.00%) 
Pulmonary embolism  1  0/353 (0.00%)  1/353 (0.28%) 
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 µg QD FSC 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   38/353 (10.76%)   25/353 (7.08%) 
Infections and infestations     
Nasopharyngitis  1  16/353 (4.53%)  8/353 (2.27%) 
Nervous system disorders     
Headache  1  23/353 (6.52%)  17/353 (4.82%) 
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: NCT01817764     History of Changes
Other Study ID Numbers: 114930
First Submitted: March 21, 2013
First Posted: March 25, 2013
Results First Submitted: April 24, 2014
Results First Posted: May 29, 2014
Last Update Posted: November 8, 2017