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Trial record 79 of 318 for:    FLUTICASONE AND SALMETEROL

A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01822899
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : May 29, 2014
Last Update Posted : September 6, 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 bromide/Vilanterol
Drug: Placebo ACCUHALER/DISKUS
Drug: Fluticasone propionate/Salmeterol
Drug: Placebo NDPI
Enrollment 717
Recruitment Details Participants who met the eligibility criteria at Screening (Visit 1) completed a 7- to 14-day Run-in Period, followed by a 12-week Treatment Period.
Pre-assignment Details A total of 717 participants, representing the enrolled participants, were randomized to study treatment. Of these, 716 participants 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 500/50 µg
Hide Arm/Group Description Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks. Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
Period Title: Overall Study
Started 358 358
Completed 334 340
Not Completed 24 18
Reason Not Completed
Adverse Event             6             5
Lack of Efficacy             6             3
Protocol Violation             6             3
Lost to Follow-up             1             0
Withdrawal by Subject             5             7
Arm/Group Title UMEC/VI 62.5/25 µg FSC 500/50 µg Total
Hide Arm/Group Description Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks. Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 358 358 716
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 358 participants 358 participants 716 participants
61.8  (7.94) 61.4  (8.06) 61.6  (8.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 358 participants 716 participants
Female
97
  27.1%
104
  29.1%
201
  28.1%
Male
261
  72.9%
254
  70.9%
515
  71.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White - White/Caucasian/European Heritage Number Analyzed 358 participants 358 participants 716 participants
358 358 716
1.Primary Outcome
Title Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One 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 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.
Time Frame Baseline and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Par. analyzed were those with data available at the presented time point but all par. without missing covariate information and with >= post BL measurement were included in the analysis.
Arm/Group Title UMEC/VI 62.5/25 µg FSC 500/50 µg
Hide Arm/Group Description:
Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
Overall Number of Participants Analyzed 332 337
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.166  (0.0122) 0.087  (0.0121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UMEC/VI 62.5/25 µg, FSC 500/50 µg
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 0.080
Confidence Interval (2-Sided) 95%
0.046 to 0.113
Estimation Comments [Not Specified]
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. BL 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 FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is 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, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL 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.
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 µg FSC 500/50 µg
Hide Arm/Group Description:
Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
Overall Number of Participants Analyzed 333 338
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.151  (0.0126) 0.062  (0.0125)
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 are 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 FSC 500/50 µg
Hide Arm/Group Description Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks. Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
All-Cause Mortality
UMEC/VI 62.5/25 µg FSC 500/50 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UMEC/VI 62.5/25 µg FSC 500/50 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   7/358 (1.96%)   2/358 (0.56%) 
Cardiac disorders     
Angina pectoris  1  1/358 (0.28%)  0/358 (0.00%) 
Gastrointestinal disorders     
Inguinal hernia  1  0/358 (0.00%)  1/358 (0.28%) 
General disorders     
Sudden cardiac death  1  1/358 (0.28%)  0/358 (0.00%) 
Infections and infestations     
Herpes zoster  1  1/358 (0.28%)  0/358 (0.00%) 
Sepsis  1  1/358 (0.28%)  0/358 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc disorder  1  0/358 (0.00%)  1/358 (0.28%) 
Renal and urinary disorders     
Renal failure acute  1  1/358 (0.28%)  0/358 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  3/358 (0.84%)  0/358 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin burning sensation  1  1/358 (0.28%)  0/358 (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 µg FSC 500/50 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   39/358 (10.89%)   32/358 (8.94%) 
Infections and infestations     
Nasopharyngitis  1  10/358 (2.79%)  11/358 (3.07%) 
Nervous system disorders     
Headache  1  33/358 (9.22%)  25/358 (6.98%) 
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: NCT01822899     History of Changes
Other Study ID Numbers: 116134
First Submitted: March 28, 2013
First Posted: April 2, 2013
Results First Submitted: April 24, 2014
Results First Posted: May 29, 2014
Last Update Posted: September 6, 2017