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Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL

RecruitingNAAges 18 Years - anyAllOttawa Hospital Research Institute
NCT06392776 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals. The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in a randomized, controlled clinical trial to determine whether early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by the primary care practitioner will improve their quality of life.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT. Exclusion Criteria: * 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
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What it tests

  • Early diagnosis and treatment
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Where

6 sites
St. Joseph's Hamilton Healthcare
Hamilton, Canada
Kingston Health Sciences Centre/Queen's University
Kingston, Canada
Ottawa Hospital General Campus
Ottawa, Canada
St. Michael's Hospital/Unity Health Toronto
Toronto, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada
Royal University Hospital
Saskatoon, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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