Undiagnosed COPD and Asthma Population Study (UCAP)

NCT03148210 | Completed DMC

• 1 other identifier: 20170182-01H
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• Annual rate of patient initiated healthcare utilization events for respiratory illness

  Number of visits for respiratory illnesses divided by the length of time in the study

  12 months

Secondary Outcomes (5)

• Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.

  12 months

• Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire

  12 months

• Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).

  12 months

• Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)

  12 months

• Smoking cessation rate

  12 months

Study Arms (2)

Enhanced Care

ACTIVE COMPARATOR

Treatment strategy using evidence-based guidelines for asthma or COPD

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

Standard of Care

PLACEBO COMPARATOR

Spirometry result sent to family MD

Behavioral: Smoking Cessation

Interventions

Treatment strategy using evidence-based guidelines for asthma or COPD 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

Enhanced Care

Smoking Cessation BEHAVIORAL

Smoking cessation counselling by a qualified educator if currently smoking

Enhanced Care; Standard of Care

Participant Education BEHAVIORAL

Standardized education for asthma or COPD disease

Enhanced Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (15)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Vancouver General Hospital- The Lung Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Micheal's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

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

Montreal, Quebec, H3H 2R9, Canada

Location

Hopital du Scaré-Coeur

Montreal, Quebec, H4J 1C5, Canada

Location

IUCP, Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 38767248 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: June 5, 2017
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (15)