Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00857766
First received: March 5, 2009
Last updated: October 18, 2012
Last verified: December 2011
Results First Received: December 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: ADVAIR DISKUS™ 250/50mcg
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FSC DISKUS 250/50 Mcg Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
Matching Placebo Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.

Participant Flow:   Overall Study
    FSC DISKUS 250/50 Mcg     Matching Placebo  
STARTED     123     126  
COMPLETED     92     96  
NOT COMPLETED     31     30  
Adverse Event                 13                 12  
Protocol Violation                 11                 11  
Lost to Follow-up                 1                 0  
Investigator Discretion                 2                 3  
Participant Withdrew Consent                 4                 4  



  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
FSC DISKUS 250/50 Mcg Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
Matching Placebo Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
Total Total of all reporting groups

Baseline Measures
    FSC DISKUS 250/50 Mcg     Matching Placebo     Total  
Number of Participants  
[units: participants]
  123     126     249  
Age  
[units: Years]
Mean ± Standard Deviation
  63.6  ± 8.92     63.5  ± 7.88     63.5  ± 8.40  
Gender  
[units: Participants]
     
Female     55     52     107  
Male     68     74     142  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     7     9     16  
American Indian or Alaska Native     1     2     3  
Asian     1     1     2  
White     114     114     228  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint   [ Time Frame: Baseline and the 12-Week Endpoint (up to Week 12) ]

2.  Secondary:   Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint   [ Time Frame: Baseline and the 12-Week Endpoint (up to Week 12) ]

3.  Secondary:   Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint   [ Time Frame: Baseline and the 12-Week Endpoint (up to Week 12) ]


  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:
Dransfield MT, Cockcroft JR, Townsend RR, Coxson HO, Sharma SS, Rubin DB, Emmett AH, Cicale MJ, Crater GD, Martinez FJ. Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. Respir Med. 2011 Sep;105(9):1322-30

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00857766     History of Changes
Other Study ID Numbers: 112355
Study First Received: March 5, 2009
Results First Received: December 16, 2010
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration