Effects of Salmeterol on Walking Capacity in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of Salmeterol on Walking Capacity in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525564
• Other study ID #: SMS106875
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2007
• Last updated: September 5, 2007
• Start date: May 2006
• Est. completion date: October 2006

Study information

• Verified date: September 2007
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Placebo
Placebo diskus inhalation powder
• Salmeterol diskus inhalation powder
50 micrograms twice a day

Locations

Country	Name	City	State
Canada	Hôpital Laval	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time during an endurance shuttle walk		acute response (2.5 hours) following the administration of the active and comparison drug
Secondary	Dyspnea during endurance shuttle walk		acute response following the administration of the study medication
Secondary	cardio-respiratory responses during an endurance shutlle walk		acute response following the administration of the study medication