Undiagnosed COPD and Asthma Population Study (UCAP)

Study Overview
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Brief Summary
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Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.

Official Title
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A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults

Conditions
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Asthma, COPD

Intervention / Treatment
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* Drug: Treatment strategy using evidence-based guidelines for asthma or COPD
* Behavioral: Smoking Cessation
* Behavioral: Participant Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects at least 18 years old; Subjects who score > or = to 6 points on The Asthma Screening Questionnaire or > 19.5 points on The COPD Diagnostic Questionnaire; Subjects who have given written informed consent to participate in this trial in accordance with local regulations; Subjects able to perform pre and post bronchodilator spirometry to measure lung function; Additional Inclusion Criteria for RCT: Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT. Exclusion Criteria: Subjects who report a previous physician diagnosis of asthma. Subjects who report a previous physician diagnosis of COPD Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery Subjects who are in the third trimester of pregnancy Subjects involved in another interventional trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Care<br>Treatment strategy using evidence-based guidelines for asthma or COPD | Drug: Treatment strategy using evidence-based guidelines for asthma or COPD<br>* The respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated<br>Behavioral: Smoking Cessation<br>* Smoking cessation counselling by a qualified educator if currently smoking<br>Behavioral: Participant Education<br>* Standardized education for asthma or COPD disease<br>|
| Placebo Comparator: Standard of Care<br>Spirometry result sent to family MD | Behavioral: Smoking Cessation<br>* Smoking cessation counselling by a qualified educator if currently smoking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual rate of patient initiated healthcare utilization events for respiratory illness | Number of visits for respiratory illnesses divided by the length of time in the study | 12 months |