The UCAP 2 Pilot Study

NCT ID: NCT06014840

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2028-12-31

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 our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.

Conditions

COPD; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Early diagnosis and treatment of COPD or Asthma

Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization

Group Type: ACTIVE_COMPARATOR

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Intervention Type: OTHER

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Delayed diagnosis and treatment of COPD or Asthma

Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks.

Group Type: OTHER

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Intervention Type: OTHER

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Interventions

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Intervention Type: OTHER

Eligibility Criteria

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

• Individuals who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy Vandemheen

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

2023

Identifier Type: -

Identifier Source: org_study_id