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| Sponsor: | Queen's University |
|---|---|
| Information provided by: | Queen's University |
| ClinicalTrials.gov Identifier: | NCT00202176 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Ipratropium Bromide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment |
| Official Title: | The Effects of Bronchodilators on Exertional Dyspnea and Exercise Performance in Mild Chronic Obstructive Pulmonary Disease (COPD) Patients and Healthy Elderly Subjects. |
| Enrollment: | 40 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Ipratropium Bromide
|
Drug: Ipratropium Bromide
Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
|
|
2: Placebo Comparator
Saline Solution (0.9% NaCl)
|
Drug: Ipratropium Bromide
Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Respiratory Investigation Unit | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Principal Investigator: | Denis E O'Donnell, MD | Queen's University-Respiratory Investigation Unit |
More Information
| Responsible Party: | Queen's University ( Dr. Denis O'Donnell ) |
| Study ID Numbers: | DMED-833-04 |
| Study First Received: | September 9, 2005 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00202176 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Chronic Obstructive Pulmonary Disease COPD |
Atrovent Ipratropium Bromide Exercise Dyspnea |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Respiration Disorders Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases |
Ipratropium Bromides Autonomic Agents Lung Diseases Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Central Nervous System Agents Anticonvulsants Pulmonary Disease, Chronic Obstructive |