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A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01395888
First received: July 14, 2011
Last updated: July 10, 2014
Last verified: August 2013
Results First Received: June 6, 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 (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI)
Drug: Tiotropium

  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
A total of 260 participants were randomized. Three of these participants were randomized in error (they were determined not to have met entry criteria and were classified as run-in/screen failures); thus, they did not receive investigational product and are not captured in the Treatment Period table of the Participant Flow module.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At Visit (V) 1, eligible participants (par.) entered a 2-week, single-blind placebo Run-in Period (RIP) to establish a stable baseline. At V 2, eligible par. were randomized to a 12-week, double-blind, double-dummy Treatment Period. 802 par. were screened, 279 par. entered the RIP, and 257 par. were randomized and received >=1 study treatment dose.

Reporting Groups
  Description
Salb/Alb + IBr Participants were provided with an inhaled short-acting beta2-receptor agonist, salbutamol/albuterol (Salb/Alb), for use as needed throughout the Run-in Period for relief of chronic obstructive pulmonary disease (COPD) symptoms. Ipratropium bromide (IBr) was permitted during the Run-in Period and for up to 4 hours prior to Randomization (Visit 2) if the participant was on a stable dose prior to Screening (Visit 1). Following randomization, IBr was not permitted during exposure to study treatment.
FF/VI 100/25 µg Participants (par.) self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
Tiotropium Bromide 18 µg Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.

Participant Flow for 2 periods

Period 1:   2-week Run-in Period
    Salb/Alb + IBr     FF/VI 100/25 µg     Tiotropium Bromide 18 µg  
STARTED     279     0     0  
COMPLETED     257     0     0  
NOT COMPLETED     22     0     0  
Adverse Event                 2                 0                 0  
Continuation Criteria Not Met                 13                 0                 0  
Lost to Follow-up                 1                 0                 0  
Protocol Violation                 2                 0                 0  
Withdrawal by Subject                 4                 0                 0  

Period 2:   Treatment Period (TP)
    Salb/Alb + IBr     FF/VI 100/25 µg     Tiotropium Bromide 18 µg  
STARTED     0     127     130  
Completed the Treatment Period     0     112 [1]   113 [1]
COMPLETED     0     112 [2]   113 [2]
NOT COMPLETED     0     15     17  
Adverse Event                 0                 7                 6  
Lack of Efficacy                 0                 4                 3  
Protocol Violation                 0                 1                 5  
Met Protocol-defined Stopping Criteria                 0                 1                 0  
Withdrawal by Subject                 0                 2                 3  
[1] Participants were considered to have completed the TP if they attended Visit 5 (Week 12).
[2] Par. completed the study if they completed the TP and a safety follow-up phone contact 1 week later.



  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 Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
Tiotropium Bromide 18 µg Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
Total Total of all reporting groups

Baseline Measures
    FF/VI 100/25 µg     Tiotropium Bromide 18 µg     Total  
Number of Participants  
[units: participants]
  127     130     257  
Age  
[units: Years]
Mean ± Standard Deviation
  66.7  ± 7.20     67.7  ± 7.34     67.3  ± 7.28  
Gender  
[units: Participants]
     
Female     19     18     37  
Male     108     112     220  
Race/Ethnicity, Customized  
[units: participants]
     
White - White/Caucasian/European     127     130     257  



  Outcome Measures

1.  Primary:   Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84)   [ Time Frame: Baseline to Day 84 (Early Withdrawal) ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01395888     History of Changes
Other Study ID Numbers: 115247
Study First Received: July 14, 2011
Results First Received: June 6, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration