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The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD

NCT00559312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-12-17

No results posted yet for this study

Summary

Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy \[i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)\] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.

Conditions

Interventions

DRUG

fluticasone/salmeterol combination

Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration

DRUG

placebo

Placebo Diskus inhaler, twice daily, 6-week duration

Sponsors & Collaborators

Principal Investigators

  • Denis E O'Donnell, MD, FRCPC · Queen's University and Kingston General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
41 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559312 on ClinicalTrials.gov