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NCT06392776From ClinicalTrials.govRecruiting

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

  • COPD
  • Asthma

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Ottawa Hospital Research Institute
Enrolment target
420
Started
16 July 2024
Main results due
December 2028
Study sites
6
Registry updated
23 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(6)

  • St. Joseph's Hamilton Healthcare

    Hamilton, Ontario, Canada

    Recruiting

  • Kingston Health Sciences Centre/Queen's University

    Kingston, Ontario, Canada

    Recruiting

  • Ottawa Hospital General Campus

    Ottawa, Ontario, Canada

    Recruiting

  • St. Michael's Hospital/Unity Health Toronto

    Toronto, Ontario, Canada

    Recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec, Canada

    Recruiting

  • Royal University Hospital

    Saskatoon, Saskatchewan, Canada

    Recruiting

Showing 6 of 6 sites. 6 of the 6 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06392776. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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