Effects of Salmeterol on Walking Capacity in Patients With COPD

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: Salmeterol diskus inhalation powder

• Registration Number: NCT00525564
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2006-05
• Study Completion: 2006-10
• Status Verified: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-05
• Last Update Submitted: 2007-09-05
• Study First Posted: 2007-09-06
• Last Update Posted: 2007-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Placebo	Placebo diskus
B	Salmeterol diskus inhalation powder	Salmeterol diskus powder

Primary Outcome Measures

Name	Time	Method
Endurance time during an endurance shuttle walk	acute response (2.5 hours) following the administration of the active and comparison drug

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Laval; 🇨🇦 Quebec City, Quebec, Canada