A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376245
First received: June 9, 2011
Last updated: January 28, 2014
Last verified: December 2013
Results First Received: December 10, 2013  
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: fluticasone furoate/vilanterol
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants (par.) completed a 2-week Run-in Period for symptom scores at baseline and to establish a stable baseline. Par. were then randomized to a 24-week (wk) Treatment Period. 880 par. were screened, 744 entered the RIP and 646 par were randomized, out of which 643 par received >=1 study treatment dose.

Reporting Groups
  Description
Placebo- Run-in Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
Placebo Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
FF /VI 50/25 µg OD Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
FF/VI 100/25 µg OD Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.

Participant Flow for 2 periods

Period 1:   2-wk Single-blind Placebo Run-in Period
    Placebo- Run-in     Placebo     FF /VI 50/25 µg OD     FF/VI 100/25 µg OD     FF/VI 200/25 µg OD  
STARTED     744     0     0     0     0  
COMPLETED     643     0     0     0     0  
NOT COMPLETED     101     0     0     0     0  
Did Not Meet Continuation Criteria                 66                 0                 0                 0                 0  
Adverse Event                 4                 0                 0                 0                 0  
Lost to Follow-up                 1                 0                 0                 0                 0  
Physician Decision                 2                 0                 0                 0                 0  
Withdrawal by Subject                 28                 0                 0                 0                 0  

Period 2:   24-week, Double-blind Treatment Period
    Placebo- Run-in     Placebo     FF /VI 50/25 µg OD     FF/VI 100/25 µg OD     FF/VI 200/25 µg OD  
STARTED     0     162     160     161     160  
COMPLETED     0     130     135     138     134  
NOT COMPLETED     0     32     25     23     26  
Adverse Event                 0                 16                 7                 8                 18  
Lack of Efficacy                 0                 4                 5                 4                 3  
Protocol Violation                 0                 2                 0                 2                 1  
Met Protocol-Defined Stopping Criteria                 0                 2                 3                 1                 0  
Lost to Follow-up                 0                 2                 0                 1                 1  
Physician Decision                 0                 0                 1                 1                 0  
Withdrawal by Subject                 0                 6                 9                 6                 3  



  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 placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
FF /VI 50/25 µg OD Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
FF/VI 100/25 µg OD Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
Total Total of all reporting groups

Baseline Measures
    Placebo     FF /VI 50/25 µg OD     FF/VI 100/25 µg OD     FF/VI 200/25 µg OD     Total  
Number of Participants  
[units: participants]
  162     160     161     160     643  
Age  
[units: Years]
Mean ± Standard Deviation
  64.7  ± 8.78     65.2  ± 8.41     65.1  ± 9.19     62.7  ± 8.65     64.4  ± 8.80  
Gender  
[units: Participants]
         
Female     16     16     12     15     59  
Male     146     144     149     145     584  
Race/Ethnicity, Customized  
[units: Participants]
         
Asian - East Asian Heritage     151     149     150     148     598  
Asian - South East Asian     11     11     11     12     45  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169   [ Time Frame: Baseline to Day 169 ]

2.  Secondary:   Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168   [ Time Frame: Baseline (BL) and Day 168 ]


  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: NCT01376245     History of Changes
Other Study ID Numbers: 113684
Study First Received: June 9, 2011
Results First Received: December 10, 2013
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration