Recruiting

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

ClinicalTrials.gov IDNCT06392776

PhaseNA

Enrollment420

SponsorOttawa Hospital Research Institute

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

COPD, Asthma

About this study

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.

Interventions

Other: Early diagnosis and treatment — Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner

Primary outcomes

Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). (12 weeks)

Eligibility information

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

Study locations

St. Joseph's Hamilton Healthcare, Hamilton, Ontario L8N 4A6 Canada
Kingston Health Sciences Centre/Queen's University, Kingston, Ontario K7L 2V6 Canada
Ottawa Hospital General Campus, Ottawa, Ontario K1H 8L6 Canada
St. Michael's Hospital/Unity Health Toronto, Toronto, Ontario Canada
Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Quebec G1V 4G5 Canada
Royal University Hospital, Saskatoon, Saskatchewan Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.