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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Ipratropium Bromide
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic, Obstructive, Pulmonary, Disease, COPD, Atrovent, Ipratropium, Bromide, Exercise, Dyspnea

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Respiratory Investigation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Ipratropium Bromide

Saline Solution (0.9% NaCl)

Outcomes

Primary Outcome Measures

endurance time
dyspnea

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
April 18, 2011
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00202176
Brief Title
Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic, Obstructive, Pulmonary, Disease, COPD, Atrovent, Ipratropium, Bromide, Exercise, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ipratropium Bromide
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Saline Solution (0.9% NaCl)
Intervention Type
Drug
Intervention Name(s)
Ipratropium Bromide
Other Intervention Name(s)
Atrovent
Intervention Description
Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
Primary Outcome Measure Information:
Title
endurance time
Time Frame
2 hours post-study drug inhalation
Title
dyspnea
Time Frame
2 hours post-study drug inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis E O'Donnell, MD
Organizational Affiliation
Queen's University-Respiratory Investigation Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Investigation Unit
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

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

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