Undiagnosed COPD and Asthma Population Study (UCAP)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Asthma; COPD

Treatments: Behavioral: Participant Education; Drug: Treatment strategy using evidence-based guidelines for asthma or COPD; Behavioral: Smoking Cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT03148210

20170182-01H

Details and patient eligibility

About

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.

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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508 participants in 2 patient groups, including a placebo group

Enhanced Care

Active Comparator group

Description:

Treatment strategy using evidence-based guidelines for asthma or COPD

Treatment:

Behavioral: Smoking Cessation

Behavioral: Participant Education

Drug: Treatment strategy using evidence-based guidelines for asthma or COPD

Standard of Care

Placebo Comparator group

Description:

Spirometry result sent to family MD

Treatment:

Behavioral: Smoking Cessation