A 24-week Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01636713
First received: July 5, 2012
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: GSK573719/VI 62.5/25
Drug: GSK573719/VI 125/25
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who met eligibility criteria at Screening (Visit 1) completed a 7 to 14-day run-in period and were then randomized to a 24-week treatment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 739 participants were screened; 580 participants were randomized in a 1:1:1 ratio to receive either one of the active treatments or placebo. One participant was randomized but data was excluded from analysis as requested by the local Ethic Committee because the participant was not consented according to the GCP standards.

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
UMEC/VI 62.5/25 µg QD Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.

Participant Flow:   Overall Study
    Placebo     UMEC/VI 62.5/25 µg QD     UMEC/VI 125/25 µg QD  
STARTED     193     194     193  
COMPLETED     161     166     170  
NOT COMPLETED     32     28     23  
Adverse Event                 16                 16                 7  
Lack of Efficacy                 6                 6                 2  
Protocol Violation                 3                 0                 1  
Lost to Follow-up                 0                 0                 1  
Withdrawal by Subject                 5                 4                 8  
Met Protocol-defined Stopping Criteria                 2                 2                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

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 (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
UMEC/VI 62.5/25 µg QD Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     UMEC/VI 62.5/25 µg QD     UMEC/VI 125/25 µg QD     Total  
Number of Participants  
[units: participants]
  193     194     193     580  
Age  
[units: Years]
Mean ± Standard Deviation
  64.3  ± 8.78     64.0  ± 8.71     63.7  ± 8.26     64.0  ± 8.57  
Gender  
[units: Participants]
       
Female     16     11     11     38  
Male     177     183     182     542  
Race/Ethnicity, Customized  
[units: Participants]
       
Asian-East Asian Heritage     170     173     173     516  
Asian-South East Asian Heritage     21     21     20     62  
Asian-Mixed Asian Heritage     2     0     0     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)   [ Time Frame: Baseline and Day 169 ]

2.  Secondary:   Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)   [ Time Frame: Day 168 (Week 24) ]

3.  Secondary:   Change From Baseline Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 1   [ Time Frame: Baseline and Day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT01636713     History of Changes
Other Study ID Numbers: 114634
Study First Received: July 5, 2012
Results First Received: May 1, 2014
Last Updated: May 22, 2014
Health Authority: Korea: Food and Drug Administration