An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323660
First received: March 24, 2011
Last updated: March 13, 2014
Last verified: December 2013
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: GSK573719/GW642444 125/25
Drug: GSK573719/GW642444 62.5/25
Drug: GSK573719 125
Drug: GSK573719 62.5
Drug: GW642444 25
Device: placebo

  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
Participants (par.) who were eligible completed a 12- to 21-day Run-in Period followed by two 12-week treatment (trt) periods.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 634 par. were enrolled and screened, 393 par. entered the Run-in Period, 308 par. were randomized and 307 par. received study trt. Participant Flow data are presented by treatment rather than sequence. Par. received 2 out of the 6 interventions.

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12weeks.
UMEC 62.5 µg QD Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
UMEC 125 µg QD Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
VI 25 µg QD Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
UMEC/VI 62.5/25 µg QD Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
UMEC 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.

Participant Flow for 3 periods

Period 1:   Treatment Period 1 (12 Weeks)
    Placebo     UMEC 62.5 µg QD     UMEC 125 µg QD     VI 25 µg QD     UMEC/VI 62.5/25 µg QD     UMEC 125/25 µg QD  
STARTED     84     22     24     36     71     70  
COMPLETED     65     21     19     31     61     61  
NOT COMPLETED     19     1     5     5     10     9  
Adverse Event                 6                 1                 1                 3                 3                 4  
Lack of Efficacy                 6                 0                 2                 0                 1                 3  
Protocol Violation                 2                 0                 1                 1                 1                 2  
Met Protocol-defined Stopping Criteria                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 5                 0                 1                 1                 3                 0  

Period 2:   Washout Period (14 Days)
    Placebo     UMEC 62.5 µg QD     UMEC 125 µg QD     VI 25 µg QD     UMEC/VI 62.5/25 µg QD     UMEC 125/25 µg QD  
STARTED     65     21     19     31     61     61  
COMPLETED     65 [1]   21 [1]   18 [1]   28 [1]   58 [1]   59 [1]
NOT COMPLETED     0     0     1     3     3     2  
Adverse Event                 0                 0                 0                 0                 1                 0  
Lack of Efficacy                 0                 0                 1                 3                 2                 2  
[1] Participants withdrawing during washout are counted under the last treatment taken.

Period 3:   Treatment Period 2 (12 Weeks)
    Placebo     UMEC 62.5 µg QD     UMEC 125 µg QD     VI 25 µg QD     UMEC/VI 62.5/25 µg QD     UMEC 125/25 µg QD  
STARTED     67 [1]   18 [1]   17 [1]   28 [1]   59 [1]   58 [1]
COMPLETED     55     17     14     25     55     51  
NOT COMPLETED     12     1     3     3     4     7  
Adverse Event                 1                 0                 0                 1                 1                 2  
Lack of Efficacy                 9                 0                 2                 2                 1                 3  
Study Closed/Terminated                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 1                 0                 0                 0                 0                 1  
Withdrawal by Subject                 1                 1                 1                 0                 2                 0  
[1] “By crossover design, participants were assigned to a different treatment arm in each period.



  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
All Study Treatments Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.

Baseline Measures
    All Study Treatments  
Number of Participants  
[units: participants]
  307  
Age  
[units: Years]
Mean ± Standard Deviation
  62.6  ± 7.88  
Gender  
[units: Participants]
 
Female     139  
Male     168  
Race/Ethnicity, Customized  
[units: Participants]
 
African American/African Heritage     6  
American Indian or Alaska Native     1  
Asian - South East Asian Heritage     1  
White - White/Caucasian/European Heritage     298  
Mixed Race     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period   [ Time Frame: Week 12 of each treatment period (up to Study Week 30) ]

2.  Primary:   Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period   [ Time Frame: Week 12 of each treatment period (up to Study Week 30) ]

3.  Secondary:   Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period   [ Time Frame: Week 12 of each treatment period (up to Study Week 30) ]

4.  Secondary:   Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period   [ Time Frame: Week 12 of each treatment period (up to Study Week 30) ]

5.  Secondary:   Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period   [ Time Frame: Week 12 of each treatment period (up to Study Week 30) ]

6.  Secondary:   Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period   [ Time Frame: Week 12 of each treatment period (up to Study Week 30) ]


  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
No text entered.


  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: NCT01323660     History of Changes
Other Study ID Numbers: 114418
Study First Received: March 24, 2011
Results First Received: December 19, 2013
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration