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NCT06392776 | RECRUITING | COPD

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

Ottawa Hospital Research Institute

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.

Condition or disease

COPD

Asthma

Intervention/treatment

Early diagnosis and treatment

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 420 participants
Masking : SINGLE
Primary Purpose : DIAGNOSTIC
Official Title : Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
Actual Study Start Date : 2024-07-16
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL

Location Details

NCT06392776

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Ontario

Ottawa Hospital General Campus

Ottawa, Ontario, Canada, K1h 8l6