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NCT06392776Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
420 (estimated)
First submitted
26 Apr 2024
Start date
16 Jul 2024
Primary completion date
Dec 2028
Lead sponsor
Ottawa Hospital Research Institute
Diseases
Asthma, COPD
NCT number
NCT06392776

What you commit to

  • Study type: Interventional
  • Planned participants: 420
  • From 16 Jul 2024 to the primary completion date, Dec 2028
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 using inhaled corticosteroids or long-acting bronchodilators.

Other illness

  • 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)

Other

  • Individuals currently under the care of a Respirologist.
  • Individuals who are in the third trimester of pregnancy
  • Individuals involved in another interventional trial

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Joseph's Hamilton Healthcare
Coordinator of this site? Confirm its status
HamiltonCanadaRecruiting
Kingston Health Sciences Centre, Queen's University
Coordinator of this site? Confirm its status
KingstonCanadaRecruiting
Ottawa Hospital - General Campus
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
Royal University Hospital
Coordinator of this site? Confirm its status
SaskatoonCanadaRecruiting
St. Michael's Hospital, Unity Health Toronto
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.