Effects of Salmeterol on Walking Capacity in Patients With COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Salmeterol on Walking Capacity in Patients With COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: Salmeterol diskus inhalation powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Placebo diskus | Drug: Placebo<br>* Placebo diskus inhalation powder<br>|
| Active Comparator: B<br>Salmeterol diskus powder | Drug: Salmeterol diskus inhalation powder<br>* 50 micrograms twice a day<br>* Other names: Serevent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance time during an endurance shuttle walk |  | acute response (2.5 hours) following the administration of the active and comparison drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), Exercise, Endurance shuttle walking test, Bronchodilation, Salmeterol