Effects of Salmeterol on Walking Capacity in Patients With COPD

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00525564
First received: September 4, 2007
Last updated: September 5, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Placebo
Drug: Salmeterol diskus inhalation powder
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Salmeterol on Walking Capacity in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 Measures:
  • Dyspnea during endurance shuttle walk [ Time Frame: acute response following the administration of the study medication ]
  • cardio-respiratory responses during an endurance shutlle walk [ Time Frame: acute response following the administration of the study medication ]

Enrollment: 28
Study Start Date: May 2006
Study Completion Date: October 2006
Arms Assigned Interventions
Placebo Comparator: A
Placebo diskus
Drug: Placebo
Placebo diskus inhalation powder
Other Name: Placebo
Active Comparator: B
Salmeterol diskus powder
Drug: Salmeterol diskus inhalation powder
50 micrograms twice a day
Other Name: Serevent

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525564

Locations
Canada, Quebec
Hôpital Laval
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
GlaxoSmithKline
Investigators
Principal Investigator: François Maltais, MD Laval University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00525564     History of Changes
Other Study ID Numbers: SMS106875
Study First Received: September 4, 2007
Last Updated: September 5, 2007
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
Exercise
Endurance shuttle walking test
Bronchodilation
Salmeterol

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Salmeterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014