Identifying and treating undiagnosed asthma or COPD in Canadians

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

This study is trying to find Canadians who might have asthma or COPD without knowing it and see if getting diagnosed and treated early can improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 4 sites (Hamilton, Ontario and 3 other locations)
• Trial ID: NCT06392776 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to identify Canadians who may have undiagnosed asthma or chronic obstructive pulmonary disease (COPD) using an online questionnaire developed by the research team. Individuals who score a certain probability of having these conditions will be invited to participate in a randomized controlled trial to assess the impact of early diagnosis and treatment on their quality of life. The study focuses on symptomatic individuals aged 18 and older who can perform lung function tests. The goal is to improve health outcomes for those with previously undiagnosed respiratory conditions.

Who should consider this trial

Good fit: Ideal candidates are symptomatic individuals aged 18 and older who score a ≥ 6% probability of having asthma or COPD based on the UCAP-Q questionnaire.

Not a fit: Patients with a previous diagnosis of asthma, COPD, or other significant lung diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved quality of life for patients with undiagnosed asthma or COPD through early diagnosis and treatment.

How similar studies have performed: Other studies have shown success in early diagnosis and treatment approaches for respiratory conditions, indicating potential for positive outcomes in this trial.

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

Where this trial is running

Hamilton, Ontario and 3 other locations

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

Study contacts

• Principal investigator: Shawn Aaron, MD — Ottawa Hospital Research Institute
• Study coordinator: Shawn Aaron, MD

Conditions COPD; Asthma