Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL (UCAP2)

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Asthma; COPD

Treatments: Other: Early diagnosis and treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06392776

Protocol ID 4373

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Early diagnosis of previously undiagnosed asthma or COPD

Experimental group

Description:

On the day of randomization the participant will receive a copy of their interpreted spirometry report with a listed diagnosis. This report will be sent to their primary-care practitioner. In addition to the spirometry interpretation, the primary-care practitioner will be provided with a brief one-page guideline-based tool providing advice for pharmacologic and non-pharmacologic treatment of newly diagnosed asthma or COPD. The primary-care practitioner will be encouraged to see the participant as soon as possible to provide care. The participant will similarly be encouraged to make an appointment with the primary-care practitioner as soon as possible to access care for their condition

Treatment:

Other: Early diagnosis and treatment

Delayed diagnosis of previously undiagnosed asthma or COPD

No Intervention group

Description:

At the 12 week visit, participants randomized to the delayed diagnosis will complete the trial outcome assessments. After completing the 12 week final trial assessments they will be seen by the study respirologist and treated for their newly diagnosed asthma or COPD.