Undiagnosed COPD and Asthma Population Study (UCAP)

NCT ID: NCT03148210

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2024-01-09

Brief Summary

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.

Conditions

Asthma; COPD

Study Design

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

Study Groups

Enhanced Care

Treatment strategy using evidence-based guidelines for asthma or COPD

Group Type: ACTIVE_COMPARATOR

Treatment strategy using evidence-based guidelines for asthma or COPD

Intervention Type: DRUG

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

Smoking Cessation

Intervention Type: BEHAVIORAL

Smoking cessation counselling by a qualified educator if currently smoking

Participant Education

Intervention Type: BEHAVIORAL

Standardized education for asthma or COPD disease

Standard of Care

Spirometry result sent to family MD

Group Type: PLACEBO_COMPARATOR

Smoking Cessation

Intervention Type: BEHAVIORAL

Smoking cessation counselling by a qualified educator if currently smoking

Interventions

Treatment strategy using evidence-based guidelines for asthma or COPD

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

Intervention Type: DRUG

Smoking Cessation

Smoking cessation counselling by a qualified educator if currently smoking

Intervention Type: BEHAVIORAL

Participant Education

Standardized education for asthma or COPD disease

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

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

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

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital- The Lung Centre

Vancouver, British Columbia, Canada

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Firestone Institute for Respiratory Health

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital-General Campus

Ottawa, Ontario, Canada

St. Micheal's Hospital

Toronto, Ontario, Canada

The Research Institute of the McGill University Health Centre (RI-MUHC)

Montreal, Quebec, Canada

Hopital du Scaré-Coeur

Montreal, Quebec, Canada

IUCP, Hôpital Laval

Québec, Quebec, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Aaron SD, Vandemheen KL, Whitmore GA, Bergeron C, Boulet LP, Cote A, McIvor RA, Penz E, Field SK, Lemiere C, Mayers I, Bhutani M, Azher T, Lougheed MD, Gupta S, Ezer N, Licskai CJ, Hernandez P, Ainslie M, Alvarez GG, Mulpuru S; UCAP Investigators. Early Diagnosis and Treatment of COPD and Asthma - A Randomized, Controlled Trial. N Engl J Med. 2024 Jun 13;390(22):2061-2073. doi: 10.1056/NEJMoa2401389. Epub 2024 May 19.

Reference Type: DERIVED

PMID: 38767248 (View on PubMed)

Other Identifiers

20170182-01H

Identifier Type: -

Identifier Source: org_study_id