Recruiting

Asthma or COPD

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06392776

Conditions

COPD

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early diagnosis and treatment

Study Details

Brief 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.

Conditions

COPD

Asthma

Study ID

NCT06392776

Start date

Jul 16, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Early diagnosis of previously undiagnosed asthma or COPD

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

no intervention: Delayed diagnosis of previously undiagnosed asthma or COPD

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.

Interventions

Early diagnosis and treatment

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

Primary outcome measure

  • Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Shawn Aaron, MD

6137378259saaron@toh.ca

Kathy Vandemheen, MScN

6137378259kvandemheen@toh.ca

Locations

St. Joseph's Hamilton Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

613-905-522-1155ljohnson@stjosham.on.ca

Ottawa Hospital General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Kathy Vandemheen

613-737-8259kvandemheen@toh.ca

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada

Contacts

Britany Duncan, MPH

(306) 966-6230britney.duncan@usask.ca

Institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Québec, Canada, G1V 4G5

Contacts

Geneviève Parent-Racine, MSc

418-656-8711genevieve.parent-racine@criucpq.ulaval.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-01-14.