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Effects of Salmeterol on Walking Capacity in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Placebo
Salmeterol diskus inhalation powder
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease (COPD), Exercise, Endurance shuttle walking test, Bronchodilation, Salmeterol

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

Placebo diskus

Salmeterol diskus powder

Outcomes

Primary Outcome Measures

Endurance time during an endurance shuttle walk

Secondary Outcome Measures

Dyspnea during endurance shuttle walk
cardio-respiratory responses during an endurance shutlle walk

Full Information

First Posted
September 4, 2007
Last Updated
September 5, 2007
Sponsor
Laval University
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00525564
Brief Title
Effects of Salmeterol on Walking Capacity in Patients With COPD
Official Title
Effects of Salmeterol on Walking Capacity in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laval University
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Exercise, Endurance shuttle walking test, Bronchodilation, Salmeterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo diskus
Arm Title
B
Arm Type
Active Comparator
Arm Description
Salmeterol diskus powder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo diskus inhalation powder
Intervention Type
Drug
Intervention Name(s)
Salmeterol diskus inhalation powder
Other Intervention Name(s)
Serevent
Intervention Description
50 micrograms twice a day
Primary Outcome Measure Information:
Title
Endurance time during an endurance shuttle walk
Time Frame
acute response (2.5 hours) following the administration of the active and comparison drug
Secondary Outcome Measure Information:
Title
Dyspnea during endurance shuttle walk
Time Frame
acute response following the administration of the study medication
Title
cardio-respiratory responses during an endurance shutlle walk
Time Frame
acute response following the administration of the study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Effects of Salmeterol on Walking Capacity in Patients With COPD

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