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A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01706328
First received: October 11, 2012
Last updated: July 24, 2014
Last verified: April 2014
Results First Received: January 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: FF/VI 100/25 Inhalation Powder NDPI
Drug: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS
Drug: Placebo Inhalation Powder NDPI
Drug: Placebo Inhalation Powder ACCUHALER/DISKUS
Drug: Salbutamol as needed

  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
Only those participants that started the Double-blind Treatment Period were considered enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At Visit 1, participants entered a 2-week, single-blind (placebo) Run-in Period to obtain Baseline assessments of salbutamol use and to evaluate adherence with study treatment and procedures, diary card completion, and assessment of disease stability. At Visit 2, participants were randomized to a 12-week, double-blind Treatment Period.

Reporting Groups
  Description
Placebo + Salbutamol Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
FF/VI 100/25 µg QD Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
FP/Salmeterol 250/50 µg BID Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.

Participant Flow for 2 periods

Period 1:   2-week Run-in Period
    Placebo + Salbutamol     FF/VI 100/25 µg QD     FP/Salmeterol 250/50 µg BID  
STARTED     993     0     0  
COMPLETED     828     0     0  
NOT COMPLETED     165     0     0  
Inclusion/Exclusion Criteria Not Met                 140                 0                 0  
Withdrawal by Subject                 15                 0                 0  
Physician Decision                 4                 0                 0  
Adverse Event                 4                 0                 0  
Lost to Follow-up                 2                 0                 0  

Period 2:   12-week Double-blind Treatment Period
    Placebo + Salbutamol     FF/VI 100/25 µg QD     FP/Salmeterol 250/50 µg BID  
STARTED     0     412     416  
COMPLETED     0     366     371  
NOT COMPLETED     0     46     45  
Adverse Event                 0                 14                 16  
Lack of Efficacy                 0                 4                 4  
Protocol Violation                 0                 4                 2  
Protocol-defined Stopping Criteria Met                 0                 11                 9  
Lost to Follow-up                 0                 3                 1  
Physician Decision                 0                 2                 2  
Withdrawal by Subject                 0                 8                 11  



  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
FF/VI 100/25 µg QD Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
FP/Salmeterol 250/50 µg BID Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
Total Total of all reporting groups

Baseline Measures
    FF/VI 100/25 µg QD     FP/Salmeterol 250/50 µg BID     Total  
Number of Participants  
[units: participants]
  412     416     828  
Age  
[units: Years]
Mean ± Standard Deviation
  61.0  ± 8.17     61.3  ± 8.37     61.1  ± 8.27  
Gender  
[units: Participants]
     
Female     111     122     233  
Male     301     294     595  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     9     5     14  
American Indian or Alaska Native     0     1     1  
White-White/Caucasian/European Heritage     403     410     813  



  Outcome Measures
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1.  Primary:   Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84   [ Time Frame: Baseline and Day 84 ]

2.  Secondary:   Time to Onset on Treatment Day 1   [ Time Frame: Baseline and Day 1 ]

3.  Secondary:   Change From Baseline in Trough FEV1 on Treatment Day 85   [ Time Frame: Baseline and Day 85 ]


  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 by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01706328     History of Changes
Other Study ID Numbers: 116974
Study First Received: October 11, 2012
Results First Received: January 23, 2014
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration