Status:
COMPLETED
A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with ri...
Detailed Description
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC) BID on arterial stiffness in COPD subjects....
Eligibility Criteria
Inclusion
- Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
- Males or females greater then or equal to 50 years of age.
- A post-albuterol FEV1/FVC ratio of \< or equal to 0.70
- A post-albuterol FEV1 \< 80% of predicted normal.
- Patients can be current or fomer smoker and must have a cigarette smoking history of \> greater then or equal to 10 pack-years .
Exclusion
- A current diagnosis of asthma
- A body mass index (BMI) of \> or equal to 35kg/m2
- A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00857766
Start Date
March 1 2009
End Date
March 1 2010
Last Update
January 30 2017
Active Locations (24)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Jasper, Alabama, United States, 35501
3
GSK Investigational Site
Mobile, Alabama, United States, 36608
4
GSK Investigational Site
Phoenix, Arizona, United States, 85006