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A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01551758
First received: March 1, 2012
Last updated: May 3, 2017
Last verified: May 2017
Results First Received: September 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: FF/VI
Other: Existing Maintenance Therapy

  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
This was a multicentre, randomized, stratified, open-label study to evaluate the effectiveness and safety of fluticasone fuorate (FF)/vilanterol (VI) in participants followed in primary care who had a diagnosis of and received regular treatment for Chronic Obstructive Pulmonary Disease (COPD).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) were randomized 1:1 to receive 1 inhalation of FF/VI 100 microgram (mcg)/25 mcg once daily (QD) or continued their existing maintenance therapy for 12 months. 2802 par. were randomized (3 par. randomized to the FF/VI arm did not receive study medication). A total of 2799 par. comprised the Intent to Treat (ITT) Population.

Reporting Groups
  Description
Usual Care Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.

Participant Flow:   Overall Study
    Usual Care   Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg
STARTED   1403   1396 
COMPLETED   1309   1291 
NOT COMPLETED   94   105 
Adverse Event                29                43 
Lack of Efficacy                0                1 
Protocol Violation                5                6 
Met Protocol-defined stopping criteria                8                10 
Lost to Follow-up                29                25 
Physician Decision                9                3 
Withdrawal by Subject                14                17 



  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
Usual Care Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
FF/VI 100 mcg/25 mcg Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
Total Total of all reporting groups

Baseline Measures
   Usual Care   FF/VI 100 mcg/25 mcg   Total 
Overall Participants Analyzed 
[Units: Participants]
 1403   1396   2799 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.7  (9.93)   66.6  (9.90)   66.7  (9.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      671  47.8%      698  50.0%      1369  48.9% 
Male      732  52.2%      698  50.0%      1430  51.1% 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American/African Heritage   3   5   8 
Asian-Central/South Asian Heritage   5   6   11 
Asian-East Asian Heritage   1   0   1 
Asian-South East Asian Heritage   1   0   1 
White-Arabic/North African Heritage   1   3   4 
White-White/Caucasian/European Heritage   1387   1376   2763 
Mixed Race   5   5   10 


  Outcome Measures
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1.  Primary:   Mean Annual Rate of Moderate or Severe COPD Exacerbations   [ Time Frame: Up to 54 weeks ]

2.  Secondary:   Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study   [ Time Frame: Up to 58 weeks ]

3.  Secondary:   Mean Number of Serious Adverse Events of Pneumonia During the Study   [ Time Frame: Up to 58 weeks ]

4.  Secondary:   Time to the First Serious Adverse Event of Pneumonia Occuring in a Year   [ Time Frame: Up to 52 weeks ]

5.  Secondary:   Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean   [ Time Frame: Up to 54 weeks ]

6.  Secondary:   Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean   [ Time Frame: Up to 54 weeks ]

7.  Secondary:   Number of All Secondary Care Contacts Expressed Using Least Square Mean   [ Time Frame: Up to 54 weeks ]

8.  Secondary:   Number of All Primary Care Contacts Expressed Using Least Square Mean   [ Time Frame: Up to 54 weeks ]

9.  Secondary:   Time to an Event of Discontinuation of Initial Therapy Occurring in a Year   [ Time Frame: Up to 364 days ]

10.  Secondary:   Time to the Addition of a Further COPD Controller Medication Occurring in a Year   [ Time Frame: Up to 364 days ]

11.  Secondary:   Time to First Moderate/Severe Exacerbations Occurring in a Year   [ Time Frame: Up to 364 days ]

12.  Secondary:   Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year   [ Time Frame: Up to 364 days ]

13.  Secondary:   Time to First Severe Exacerbations Occurring in a Year   [ Time Frame: Up to 364 days ]

14.  Secondary:   Number of Participants With Fatal Serious Adverse Events of Pneumonia   [ Time Frame: Upto 58 weeks ]

15.  Secondary:   Number of Participants With Non-serious Adverse Drug Reactions (ADR)   [ Time Frame: Up to 54 weeks ]

16.  Secondary:   Number of Participants With Serious Adverse Events   [ Time Frame: Up to 56 weeks ]

17.  Secondary:   Number of Participants With Serious Adverse Drug Reactions   [ Time Frame: Upto 12 months ]


  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
No text entered.


  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


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01551758     History of Changes
Other Study ID Numbers: 115151
Study First Received: March 1, 2012
Results First Received: September 5, 2016
Last Updated: May 3, 2017