Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Exercise, Endurance shuttle walking test, Bronchodilation, Salmeterol
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Placebo diskus inhalation powder
DRUGSalmeterol diskus inhalation powder
50 micrograms twice a day
Sponsors
GlaxoSmithKline
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age \> 50 years * smoking history \> 10 packs/year * FEV1 \< 70% of predicted and FEV1/FVC \< 70%.
Exclusion criteria
* respiratory exacerbation within the 2 months preceding the study * history of asthma * significant O2 desaturation (SaO2 \< 85%) at rest or during exercise * presence of another pathology that could influence exercise tolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endurance time during an endurance shuttle walk | acute response (2.5 hours) following the administration of the active and comparison drug |
Secondary
| Measure | Time frame |
|---|---|
| Dyspnea during endurance shuttle walk | acute response following the administration of the study medication |
| cardio-respiratory responses during an endurance shutlle walk | acute response following the administration of the study medication |
Countries
Canada
Outcome results
None listed