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A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT00731822
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : August 15, 2013
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Intervention Drug: GW685698/GW642444
Enrollment 60
Recruitment Details  
Pre-assignment Details Participants meeting eligibility criteria at screening and randomization criteria at the end of the Screening Period (SP) were randomized to 1 of 2 treatments: Fluticasone Furoate (FF)/Vilanterol (GW642444) 400/25 microgram (µg) inhalation powder or matching placebo. 89 participants were screened, of whom 60 were randomized.
Arm/Group Title Placebo FF/VI 400/25 µg OD
Hide Arm/Group Description Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days. Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
Period Title: Overall Study
Started 20 40
Completed 16 39
Not Completed 4 1
Reason Not Completed
Adverse Event             2             1
Protocol Violation             1             0
Lost to Follow-up             1             0
Arm/Group Title Placebo FF/VI 400/25 µg OD Total
Hide Arm/Group Description Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days. Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 20 40 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 40 participants 60 participants
63.8  (6.01) 63.5  (7.10) 63.6  (6.71)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
Female
5
  25.0%
15
  37.5%
20
  33.3%
Male
15
  75.0%
25
  62.5%
40
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 20 participants 40 participants 60 participants
20 40 60
1.Primary Outcome
Title Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period
Hide Description Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.
Time Frame Baseline to Day 28
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. The 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 >=1 post-BL measurement are included in the analysis.
Arm/Group Title Placebo FF/VI 400/25 µg OD
Hide Arm/Group Description:
Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
Overall Number of Participants Analyzed 20 40
Least Squares Mean (Standard Error)
Unit of Measure: Beats per minute (bpm)
-5.7  (1.83) -5.1  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FF/VI 400/25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-3.9 to 5.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study
Hide Description Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.
Time Frame From Baseline (Day 1) until Follow-up (up to Study Day 37)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo FF/VI 400/25 µg OD
Hide Arm/Group Description:
Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
Overall Number of Participants Analyzed 20 40
Measure Type: Number
Unit of Measure: participants
Any AE 10 27
Any SAE 0 1
3.Secondary Outcome
Title Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29
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. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.
Time Frame Baseline; Day 2, Day 15, and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.
Arm/Group Title Placebo FF/VI 400/25 µg OD
Hide Arm/Group Description:
Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
Overall Number of Participants Analyzed 20 40
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 2, n=20, 39 0.122  (0.0323) 0.276  (0.0229)
Day 15, n=15, 39 0.113  (0.0387) 0.285  (0.0253)
Day 29, n=16, 39 0.088  (0.0398) 0.271  (0.0262)
4.Secondary Outcome
Title Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28
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. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.
Time Frame Baseline (pre-dose on Day 1); Day 1 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.
Arm/Group Title Placebo FF/VI 400/25 µg OD
Hide Arm/Group Description:
Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
Overall Number of Participants Analyzed 20 40
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 1, n=20, 40 0.022  (0.0259) 0.222  (0.0182)
Day 28, n=16, 39 0.047  (0.0341) 0.283  (0.0227)
Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication through the study treatment stop date (Day 28 +1).
Adverse Event Reporting Description An on-therapy 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/VI 400/25 µg OD
Hide Arm/Group Description Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days. Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
All-Cause Mortality
Placebo FF/VI 400/25 µg OD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo FF/VI 400/25 µg OD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   1/40 (2.50%) 
Gastrointestinal disorders     
Colitis ulcerative  1  0/20 (0.00%)  1/40 (2.50%) 
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%
Placebo FF/VI 400/25 µg OD
Affected / at Risk (%) Affected / at Risk (%)
Total   10/20 (50.00%)   16/40 (40.00%) 
Gastrointestinal disorders     
Dry mouth  1  1/20 (5.00%)  0/40 (0.00%) 
General disorders     
Chest pain  1  1/20 (5.00%)  1/40 (2.50%) 
Pyrexia  1  1/20 (5.00%)  0/40 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  3/20 (15.00%)  7/40 (17.50%) 
Oral candidiasis  1  0/20 (0.00%)  3/40 (7.50%) 
Urinary tract infection  1  1/20 (5.00%)  0/40 (0.00%) 
Investigations     
Electrocardiogram abnormal  1  1/20 (5.00%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/20 (5.00%)  0/40 (0.00%) 
Nervous system disorders     
Headache  1  1/20 (5.00%)  6/40 (15.00%) 
Dizziness  1  1/20 (5.00%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  0/20 (0.00%)  2/40 (5.00%) 
Dyspnoea  1  1/20 (5.00%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema  1  1/20 (5.00%)  0/40 (0.00%) 
Hyperhidrosis  1  1/20 (5.00%)  0/40 (0.00%) 
Rash  1  1/20 (5.00%)  0/40 (0.00%) 
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: NCT00731822     History of Changes
Other Study ID Numbers: HZC111348
First Submitted: August 8, 2008
First Posted: August 11, 2008
Results First Submitted: June 12, 2013
Results First Posted: August 15, 2013
Last Update Posted: December 8, 2016