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: June 29, 2016
Last verified: June 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  
Number of Participants  
[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: June 29, 2016
Health Authority: United States: Food and Drug Administration