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

Recruiting now · Not applicable

Conditions studied: COPD, Asthma

In brief

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.

Key facts

Study ID

NCT06392776

Run by

Ottawa Hospital Research Institute

People needed

420

Starts

2024-07-16

Expected to finish

2029-12-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• St. Joseph's Hamilton Healthcare — Hamilton, Ontario, Canada (enrolling)
• Ottawa Hospital General Campus — Ottawa, Ontario, Canada (enrolling)
• Royal University Hospital — Saskatoon, Saskatchewan, Canada (enrolling)
• Institut universitaire de cardiologie et de pneumologie de Québec — Québec, Canada (enrolling)

Full record on ClinicalTrials.gov

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