We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00857766
First Posted: March 9, 2009
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: December 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      55  44.7%      52  41.3%      107  43.0% 
Male      68  55.3%      74  58.7%      142  57.0% 
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00857766     History of Changes
Other Study ID Numbers: 112355
First Submitted: March 5, 2009
First Posted: March 9, 2009
Results First Submitted: December 16, 2010
Results First Posted: December 23, 2010
Last Update Posted: January 30, 2017