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

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

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

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Fluticasone; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Arm 1: drug, crossing over to Pbo comparator	Drug: Fluticasone; fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
Other: 2; Arm 2: Pbo comparator, crossing over to drug	Drug: Fluticasone; fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.; Drug: Comparator: Placebo; Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Endurance Time	Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.	2 Weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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 2011 Sep 13.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 5, 2006
• First Submitted That Met QC Criteria: October 11, 2006
• First Posted (Estimate): October 12, 2006

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone
• Other Study ID Numbers: 0000-036; 036; 2006_039