Status:
WITHDRAWN
The UCAP 2 Pilot Study
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
COPD
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life. The i...
Eligibility Criteria
Inclusion
- Individuals at least 18 years old
- Individuals must be symptomatic with respiratory symptoms
- Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
- Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
- Individual must be able to perform pre and post bronchodilator spirometry to measure lung function
- Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):
- Individuals who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (FEV1) improves by \> 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to participate in the RCT.
Exclusion
- Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
- Individuals currently under the care of a respirologist
- Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
- Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
- Individuals who are in the third trimester of pregnancy
- Individuals involved in another interventional trial
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06014840
Start Date
September 1 2023
End Date
December 1 2028
Last Update
April 25 2024
Active Locations (1)
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1
Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6