Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

Phase 2

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Fluticasone

• Registration Number: NCT00387036
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-12
• Study Start: 2006-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2010-04-08
• Results First Submitted QC: 2010-04-30
• Results First Posted: 2010-05-26
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 40 years and older
• Clinical diagnosis of COPD for greater than one year
• History of cigarette smoking

Exclusion Criteria

• Other lung diseases (not including COPD), such as asthma
• A condition that could interfere with your ability to perform exercise tests

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Fluticasone	Arm 2: Pbo comparator, crossing over to drug
1	Fluticasone	Arm 1: drug, crossing over to Pbo comparator

Primary Outcome Measures

Name	Time	Method
Standardized Dyspnea Score at Isotime During Exercise	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 \[Worst\] ).

Secondary Outcome Measures

Name	Time	Method
Exercise Endurance Time	2 Weeks	Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.