Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Bronchodilators on Exertional Dyspnea and Exercise Performance in Mild Chronic Obstructive Pulmonary Disease (COPD) Patients and Healthy Elderly Subjects. |
- endurance time [ Time Frame: 2 hours post-study drug inhalation ] [ Designated as safety issue: No ]
- dyspnea [ Time Frame: 2 hours post-study drug inhalation ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Ipratropium Bromide
|
Drug: Ipratropium Bromide
Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
Other Name: Atrovent
|
|
Placebo Comparator: 2
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.
Other Name: Atrovent
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
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
No publications provided
| Responsible Party: | Dr. Denis O'Donnell, Queen's University |
| ClinicalTrials.gov Identifier: | NCT00202176 History of Changes |
| Other Study ID Numbers: | DMED-833-04 |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 18, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Queen's University:
|
Chronic Obstructive Pulmonary Disease COPD |
Atrovent Ipratropium Bromide Exercise Dyspnea |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Bronchodilator Agents Ipratropium Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013