A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00857766|
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : December 23, 2010
Last Update Posted : January 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: ADVAIR DISKUS™ 250/50mcg Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)|
|Study Start Date :||March 2009|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
Active Comparator: ADVAIR DISKUS
Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Drug: ADVAIR DISKUS™ 250/50mcg
ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Placebo Comparator: Placebo
Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER
COPD subjects-Placebo DISKUS
- 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) ]The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.
- 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) ]AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.
- 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) ]FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857766
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|