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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00387036
• Other study ID #: 0000-036
• Secondary ID: 0362006_039
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: December 17, 2015
• Start date: December 2006
• Est. completion date: July 2009

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
• Comparator: Placebo
Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respir Med. 2011 Dec;105(12):1836-45. doi: 10.1016/j.rmed.2011.08.021. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized Dyspnea Score at Isotime During Exercise	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] ).	2 Weeks	No
Secondary	Exercise Endurance Time	Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.	2 Weeks	No