Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
|ClinicalTrials.gov Identifier: NCT00387036|
Recruitment Status : Terminated (Termininated for business reasons)
First Posted : October 12, 2006
Results First Posted : May 26, 2010
Last Update Posted : January 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: Fluticasone Drug: Comparator: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
- Standardized Dyspnea Score at Isotime During Exercise [ Time Frame: 2 Weeks ]
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 ]Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387036
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|