Undiagnosed COPD and Asthma Population Study (UCAP)

Asthma Clinical Trial

Official title:

A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148210
• Other study ID #: 20170182-01H
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: January 9, 2024

Study information

• Verified date: March 2024
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Additional Inclusion Criteria for RCT:

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

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Drug:
• 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

Behavioral:
• Smoking Cessation
Smoking cessation counselling by a qualified educator if currently smoking
• Participant Education
Standardized education for asthma or COPD disease

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
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 Research Institute of the McGill University Health Centre (RI-MUHC)	Montreal	Quebec
Canada	Hopital du Scaré-Coeur	Montréal	Quebec
Canada	The Ottawa Hospital-General Campus	Ottawa	Ontario
Canada	IUCP, Hôpital Laval	Québec City	Quebec
Canada	St. Clare's Mercy Hospital	Saint John's	Newfoundland and Labrador
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	St. Micheal's Hospital	Toronto	Ontario
Canada	Vancouver General Hospital- The Lung Centre	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.	The change will be expressed as the mean change in the FEV1 measurements at 12 months in comparison to the lung function measurements on the day of randomization.	12 months
Secondary	Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire	The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 months minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status.	12 months
Secondary	Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).	The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 months minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.	12 months
Secondary	Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)	The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 months minus the score on the day of randomization. A total change of - 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden.	12 months
Secondary	Smoking cessation rate	The number of participants who quit smoking over the 12 month period.	12 months