Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 2 for:    CARDIOVASCULAR VILANTEROL POWDER

Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01313676
First received: February 3, 2011
Last updated: October 24, 2016
Last verified: October 2016
Results First Received: March 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: fluticasone furoate/vilanterol
Drug: fluticasone furoate
Drug: vilanterol
Other: 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
This study was conducted at 1373 sites. The study employed an event-driven design and was to conclude when approximately 1000 reports of a primary outcome event of death were received. The study consisted of a 4-10 day run-in period, variable treatment period until the required number of events was achieved, and 1 week follow-up period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 23,835 participants were screened, of whom 16,590 were randomized. Of the 16,590 participants randomized, 16,568 participants received a single dose of investigational product (IP) and were assigned to a treatment and included in the Safety Population.

Reporting Groups
  Description
Placebo Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Fluticasone Furoate 100 µg Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Vilanterol 25 µg Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Fluticasone Furoate/Vilanterol 100/25 µg Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.

Participant Flow:   Overall Study
    Placebo   Fluticasone Furoate 100 µg   Vilanterol 25 µg   Fluticasone Furoate/Vilanterol 100/25 µg
STARTED   4131   4157   4140   4140 
COMPLETED   2881   3044   3052   3146 
NOT COMPLETED   1250   1113   1088   994 
Adverse Event                395                365                372                333 
Lack of Efficacy                98                90                65                46 
Protocol Violation                37                44                46                44 
Met Protocol-Defined Stopping Critera                3                4                2                11 
Study Closed/terminated                7                6                9                9 
Lost to Follow-up                0                0                1                0 
Physician Decision                53                64                62                48 
Decision by Participant or Proxy                643                527                515                492 
Sponsor Terminated Study Treatment                1                1                0                1 
Investigator Site Closed                12                11                15                10 
Missing                1                1                1                0 



  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 from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Fluticasone Furoate 100 µg Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Vilanterol 25 µg Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Fluticasone Furoate/Vilanterol 100/25 µg Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Total Total of all reporting groups

Baseline Measures
   Placebo   Fluticasone Furoate 100 µg   Vilanterol 25 µg   Fluticasone Furoate/Vilanterol 100/25 µg   Total 
Overall Participants Analyzed 
[Units: Participants]
 4131   4157   4140   4140   16568 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.2  (7.90)   65.0  (8.02)   65.2  (7.68)   65.3  (7.97)   65.2  (7.89) 
Gender 
[Units: Participants]
         
Female   1050   1098   1071   1019   4238 
Male   3081   3059   3069   3121   12330 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American /African Heritage   61   62   68   69   260 
American Indian or Alaskan Native   9   5   4   9   27 
Asian - Central /South Asian Heritage   64   55   62   57   238 
Asian - East Asian Heritage   192   193   195   192   772 
Asian - Japanese Heritage   34   36   37   37   144 
Asian - Mixed Race   1   0   0   0   1 
Asian - South East Asian Heritage   389   399   386   394   1568 
Native Hawaiian or Other Pacific Islander   1   2   0   2   5 
White - Arabic/North African Heritage   14   13   7   12   46 
White - Mixed Race   0   0   0   1   1 
White - White/Caucasian /European Heritage   3334   3367   3353   3337   13391 
Mixed Race   32   25   28   30   115 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date   [ Time Frame: From the date of randomization until date of death due to any cause (average of 2 study years) ]

2.  Secondary:   Decline in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: From start date of IP until IP stop date + 1 (assessed up to 4 years) ]

3.  Secondary:   Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date   [ Time Frame: From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years) ]


  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: NCT01313676     History of Changes
Other Study ID Numbers: 113782
Study First Received: February 3, 2011
Results First Received: March 10, 2016
Last Updated: October 24, 2016
Health Authority: United States: Food and Drug Administration