A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD (DB2113361)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01313637
First received: March 10, 2011
Last updated: February 20, 2014
Last verified: February 2014
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: GSK573719/GW642444 125/25mcg
Drug: GSK573719 125mcg
Drug: GW642444 25mcg
Drug: Placebo only

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to14-day run-in period and were then randomized to a 24-week treatment (trt.) period. A total of 2114 participants were screened; 1493 participants were randomized, and 1489 participants took at least one dose of randomized medication.

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
UMEC 125 µg QD Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD via a DPI in the morning for 24 weeks.
VI 25 µg QD Participants received vilanterol (VI) 25 µg QD via a DPI 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 125 µg QD     VI 25 µg QD     UMEC/VI 125/25 µg QD  
STARTED     275     407     404     403  
COMPLETED     183     312     298     325  
NOT COMPLETED     92     95     106     78  
Adverse Event                 17                 24                 25                 18  
Lack of Efficacy                 44                 38                 37                 24  
Protocol Violation                 4                 3                 11                 5  
Met Protocol- Defined Stopping Criteria                 16                 15                 14                 13  
Lost to Follow-up                 0                 2                 1                 3  
Withdrawal by Subject                 11                 13                 18                 15  



  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.
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Reporting Groups
  Description
Placebo Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
UMEC 125 µg Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
VI 25 µg Participants received VI 25 µg QD via a DPI for 24 weeks.
UMEC/VI 125/25 µg 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 125 µg     VI 25 µg     UMEC/VI 125/25 µg     Total  
Number of Participants  
[units: participants]
  275     407     404     403     1489  
Age  
[units: Years]
Mean ± Standard Deviation
  62.2  ± 8.53     63.1  ± 8.48     62.8  ± 8.80     63.4  ± 8.08     62.9  ± 8.47  
Gender  
[units: Participants]
         
Female     100     137     139     139     515  
Male     175     270     265     264     974  
Race/Ethnicity, Customized  
[units: Participants]
         
African American/African Heritage     9     4     7     4     24  
American Indian or Alaska Native     0     0     1     1     2  
Asian - Central/South Asian Heritage     0     0     1     0     1  
Asian - Japanese Heritage     13     21     21     19     74  
Asian - South East Asian Heritage     14     19     20     20     73  
White - Arabic/North African Heritage     1     2     1     0     4  
White - White/Caucasian/European Heritage     237     361     353     359     1310  
Mixed Race     1     0     0     0     1  



  Outcome Measures
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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:   Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)   [ Time Frame: Day 168 (Week 24) ]

3.  Secondary:   Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168   [ Time Frame: Baseline and Day 168 ]

4.  Other Pre-specified:   Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24   [ Time Frame: Baseline and Week 24 ]


  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: NCT01313637     History of Changes
Other Study ID Numbers: 113361, 2010-023348-33
Study First Received: March 10, 2011
Results First Received: December 19, 2013
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration