Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Comparator: Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease|
- Standardized Dyspnea Score at Isotime During Exercise [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] ).
- Exercise Endurance Time [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
|Study Start Date:||December 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Arm 1: drug, crossing over to Pbo comparator
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
Arm 2: Pbo comparator, crossing over to drug
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.Drug: Comparator: Placebo
Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387036
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|