Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT00202176
Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Ipratropium Bromide in people with Chronic Obstructive Pulmonary Disease (COPD), run by Queen's University at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Ipratropium Bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bronchodilators on Exertional Dyspnea and Exercise Performance in Mild Chronic Obstructive Pulmonary Disease (COPD) Patients and Healthy Elderly Subjects.
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.
Read the 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.
- Being tested
- Ipratropium Bromide
- Keywords
- Chronic, Obstructive, Pulmonary, Disease, COPD, Atrovent, Ipratropium, Bromide, Exercise, Dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiolitis Obliterans Syndrome, Disease, Motor Activity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium BromideDrug
Also called Atrovent
Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ipratropium Bromide Receives: Drug: Ipratropium Bromide |
| 2 | Placebo comparator | Saline Solution (0.9% NaCl) Receives: Drug: Ipratropium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
endurance time
Measured: 2 hours post-study drug inhalation
dyspnea
Measured: 2 hours post-study drug inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Denis E O'Donnell, MD, Principal investigator, Queen's University-Respiratory Investigation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202176
- Sponsor's protocol ID
- DMED-833-04
- Status last verified
- Apr 2011
- First submitted
- 9 Sep 2005
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bronchodilators on Exertional Dyspnea and Exercise Performance in Mild Chronic Obstructive Pulmonary Disease (COPD) Patients and Healthy Elderly Subjects.
- ClinicalTrials.gov ID
- NCT00202176
- Acronym / sponsor ID
- DMED-833-04
- Keywords
- Chronic, Obstructive, Pulmonary, Disease, COPD, Atrovent, Ipratropium, Bromide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ipratropium BromideIpratropium Bromide |
| 2 | Placebo comparator | Drug: Ipratropium BromideSaline Solution (0.9% NaCl) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipratropium BromideAlso: AtroventNebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only. | Drug | 1, 2 |
Primary outcome
endurance time
Time frame: 2 hours post-study drug inhalation
dyspnea
Time frame: 2 hours post-study drug inhalation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis E O'Donnell, MD principal investigator
Queen's University-Respiratory Investigation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ipratropium Bromide in people with Chronic Obstructive Pulmonary Disease (COPD), run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endurance time (time frame: 2 hours post-study drug inhalation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.