Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Salmeterol on Walking Capacity in Patients With COPD
This study was designed to test the following hypothesis:
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.
Background: Little is known about the responsiveness of the endurance shuttle walking test
(ESWT) to pharmacotherapy in patients with chronic obstructive pulmonary disease (COPD).
This exercise testing modality needs to be further investigated because of its relevance for
activity of daily living.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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