A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01342913
First received: April 14, 2011
Last updated: December 12, 2013
Last verified: December 2013
Results First Received: May 30, 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 100mcg/Vilanterol 25mcg
Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg

  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
No text entered.

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 (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (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.
Salmeterol/FP 50/500 µg BID Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
FF/VI 100/25 µg QD Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.

Participant Flow for 2 periods

Period 1:   2-week Run-in Period
    Placebo + Salbutamol     Salmeterol/FP 50/500 µg BID     FF/VI 100/25 µg QD  
STARTED     702     0     0  
COMPLETED     528     0     0  
NOT COMPLETED     174     0     0  
Inclusion/Exclusion Criteria Not Met                 66                 0                 0  
Physician Decision                 6                 0                 0  
Withdrawal by Subject                 7                 0                 0  
Adverse Event                 2                 0                 0  
Protocol Violation                 5                 0                 0  
Continuation Criteria Not Met                 88                 0                 0  

Period 2:   Double-Blind Treatment Period
    Placebo + Salbutamol     Salmeterol/FP 50/500 µg BID     FF/VI 100/25 µg QD  
STARTED     0     262     266  
COMPLETED     0     246     243  
NOT COMPLETED     0     16     23  
Adverse Event                 0                 3                 6  
Lack of Efficacy                 0                 2                 3  
Protocol Violation                 0                 6                 9  
Lost to Follow-up                 0                 1                 3  
Physician Decision                 0                 2                 0  
Withdrawal by Subject                 0                 2                 2  



  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
Salmeterol/FP 50/500 µg BID Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
FF/VI 100/25 µg QD Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Salmeterol/FP 50/500 µg BID     FF/VI 100/25 µg QD     Total  
Number of Participants  
[units: participants]
  262     266     528  
Age  
[units: Years]
Mean ± Standard Deviation
  62.9  ± 9.07     63.0  ± 8.10     62.9  ± 8.59  
Gender  
[units: Participants]
     
Female     41     54     95  
Male     221     212     433  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     1     0     1  
Asian-South East Asian Heritage     53     48     101  
White-Arabic/North African Hertage     2     1     3  
White/Caucasian/European Heritage     206     217     423  



  Outcome Measures
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1.  Primary:   Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84   [ Time Frame: Baseline and Day 84 ]

2.  Secondary:   Time to Onset on Treatment Day 1   [ Time Frame: 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: NCT01342913     History of Changes
Other Study ID Numbers: 113107
Study First Received: April 14, 2011
Results First Received: May 30, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration
Europe: European Medicines Agency