NCT06392776 Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
| NCT ID | NCT06392776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-07-16 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2024-07-16 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Shawn Aaron, MD
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06392776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06392776 currently recruiting?
Yes, NCT06392776 is actively recruiting participants. Contact the research team at saaron@toh.ca for enrollment information.
Where is the NCT06392776 trial being conducted?
This trial is being conducted at Hamilton, Canada, Ottawa, Canada, Saskatoon, Canada, Québec, Canada.
Who is sponsoring the NCT06392776 clinical trial?
NCT06392776 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Shawn Aaron, MD at Ottawa Hospital Research Institute. The trial plans to enroll 420 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.