Official Title: “The Effects of Bronchodilators on Exertional Dyspnea and Exercise Performance in Mild Chronic Obstructive Pulmonary Disease (COPD) Patients and Healthy Elderly Subjects.”

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation).

Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Study Primary Completion Date: December 2008

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest - this is known as lung hyperinflation. We believe that breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing; this medication can reduce coughing, wheezing and shortness of breath.

Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

Each subject will attend 4 visits to the laboratory. Visit 1 (screening visit) will involve a record of medical history, medications used, anthropometrics measurements, questionnaires, breathing tests, an incremental cycle exercise test and a constant-workload cycle exercise test. Visit 2 will involve breathing tests and a constant-workload cycle exercise test.

Visits 3 and 4 will involve breathing tests and a constant-workload cycle exercise test after subjects have been randomized to either placebo or Atrovent. These visits will be done on separate days and subjects will receive the two above treatments in random order.

Intervention(s) in this Clinical Trial

• Drug: Ipratropium Bromide
  • Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ipratropium Bromide
• Placebo Comparator: 2
  • Saline Solution (0.9% NaCl)

Primary Measures

• endurance time
  • Time Frame: 2 hours post-study drug inhalation
    Safety Issue?: No
• dyspnea
  • Time Frame: 2 hours post-study drug inhalation
    Safety Issue?: No

Inclusion Criteria:

• diagnosis of mild COPD OR healthy control subjects
• 40-80 years old
• able to perform all study procedures
• Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects)

Exclusion Criteria:

• allergy to atrovent
• history of asthma, atopy or nasal polyps
• Oxygen desaturation < 80 % during exercise
• recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

Denis E O'Donnell, MD Principal Investigator Queen's University-Respiratory Investigation Unit  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00202176

Study ID Number: DMED-833-04

ClinicalTrials.gov Identifier: NCT00202176

Health Authority: Canada: Health Canada