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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731822
First received: August 8, 2008
Last updated: April 17, 2014
Last verified: April 2014
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Intervention: Drug: GW685698/GW642444

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
FF/VI 400/25 µg OD Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.

Participant Flow:   Overall Study
    Placebo     FF/VI 400/25 µg OD  
STARTED     20     40  
COMPLETED     16     39  
NOT COMPLETED     4     1  
Adverse Event                 2                 1  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
FF/VI 400/25 µg OD Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
Total Total of all reporting groups

Baseline Measures
    Placebo     FF/VI 400/25 µg OD     Total  
Number of Participants  
[units: participants]
  20     40     60  
Age  
[units: Years]
Mean ± Standard Deviation
  63.8  ± 6.01     63.5  ± 7.10     63.6  ± 6.71  
Gender  
[units: Participants]
     
Female     5     15     20  
Male     15     25     40  
Race/Ethnicity, Customized  
[units: participants]
     
White     20     40     60  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period   [ Time Frame: Baseline to Day 28 ]

2.  Primary:   Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study   [ Time Frame: From Baseline (Day 1) until Follow-up (up to Study Day 37) ]

3.  Secondary:   Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29   [ Time Frame: Baseline; Day 2, Day 15, and Day 29 ]

4.  Secondary:   Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28   [ Time Frame: Baseline (pre-dose on Day 1); Day 1 and Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00731822     History of Changes
Other Study ID Numbers: HZC111348
Study First Received: August 8, 2008
Results First Received: June 12, 2013
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration