Early diagnosis and treatment: Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). — 12 weeks The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.
Trial sites (6)
Facility
City
Region
Status
St. Joseph's Hamilton Healthcare
Hamilton
Ontario
Recruiting
Kingston Health Sciences Centre/Queen's University
Kingston
Ontario
Recruiting
Ottawa Hospital General Campus
Ottawa
Ontario
Recruiting
St. Michael's Hospital/Unity Health Toronto
Toronto
Ontario
Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec
Quebec
Recruiting
Royal University Hospital
Saskatoon
Saskatchewan
Recruiting
More Ottawa Hospital Research Institute trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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