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

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ClinicalTrials.gov Identifier: NCT00202176
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Queen's University

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Ipratropium Bromide Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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.
Study Start Date : July 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. endurance time [ Time Frame: 2 hours post-study drug inhalation ]
  2. dyspnea [ Time Frame: 2 hours post-study drug inhalation ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202176


Locations
Canada, Ontario
Respiratory Investigation Unit
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Denis E O'Donnell, MD Queen's University-Respiratory Investigation Unit

Responsible Party: Dr. Denis O'Donnell, Queen's University
ClinicalTrials.gov Identifier: NCT00202176     History of Changes
Other Study ID Numbers: DMED-833-04
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011

Keywords provided by Queen's University:
Chronic
Obstructive
Pulmonary
Disease
COPD
Atrovent
Ipratropium
Bromide
Exercise
Dyspnea

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Bronchodilator Agents
Ipratropium
Anticonvulsants
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