Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202176
• Other study ID #: DMED-833-04
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: April 18, 2011
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: April 2011
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Respiratory Investigation Unit	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endurance time		2 hours post-study drug inhalation	No
Primary	dyspnea		2 hours post-study drug inhalation	No