Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: August 25, 2016
Last verified: August 2016
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
  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
No text entered.

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
  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 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 
Overall Participants Analyzed 
[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
  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:   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
  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01313637     History of Changes
Other Study ID Numbers: 113361
2010-023348-33 ( EudraCT Number )
Study First Received: March 10, 2011
Results First Received: December 19, 2013
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration