Effects of Salmeterol on Walking Capacity in Patients With COPD
NCT ID: NCT00525564
Last Updated: 2007-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
28 participants
INTERVENTIONAL
2006-05-31
2006-10-31
Brief Summary
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The acute changes in exercise tolerance during the endurance shuttle walk will be greater with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.
Detailed Description
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Objective: To evaluate, in patients with COPD, the responsiveness of the ESWT to detect improvement in walking performance after single dose of salmeterol.
Methods: In a randomised, double-blind, placebo-controlled, crossover study, 20 patients with COPD will perform, on two separate days, an ESWT at 80% of peak capacity, 2 hours after inhaling either a placebo or 50µg of salmeterol. Cardiorespiratory parameters will be monitored breath-by-breath during each walking test with a portable telemetric gas analyzer (Oxycom Mobile, Jaeger, Germany). Inspiratory capacities and Borg ratings for dyspnea were obtained every other minute throughout the tests.
Planned analysis. The main outcome will be endurance time. This variable will be compared between the two treatment arms using a paired t test. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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A
Placebo diskus
Placebo
Placebo diskus inhalation powder
B
Salmeterol diskus powder
Salmeterol diskus inhalation powder
50 micrograms twice a day
Interventions
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Placebo
Placebo diskus inhalation powder
Salmeterol diskus inhalation powder
50 micrograms twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* smoking history \> 10 packs/year
* FEV1 \< 70% of predicted and FEV1/FVC \< 70%.
Exclusion Criteria
* history of asthma
* significant O2 desaturation (SaO2 \< 85%) at rest or during exercise
* presence of another pathology that could influence exercise tolerance.
50 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Laval University
OTHER
Principal Investigators
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François Maltais, MD
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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Hôpital Laval
Québec, Quebec, Canada
Countries
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Other Identifiers
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SMS106875
Identifier Type: -
Identifier Source: org_study_id