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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Care | Active Comparator | Treatment strategy using evidence-based guidelines for asthma or COPD |
|
| Standard of Care | Placebo Comparator | Spirometry result sent to family MD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38767248 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 30, 2024 | |
| Reset | Dec 13, 2024 |
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|
| Smoking Cessation | Behavioral | Smoking cessation counselling by a qualified educator if currently smoking |
|
| Participant Education | Behavioral | Standardized education for asthma or COPD disease |
|
| 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 |
| 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 |
| 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 |
| Smoking cessation rate | The number of participants who quit smoking over the 12 month period. | 12 months |
| Edmonton |
| Alberta |
| T6G 2C8 |
| Canada |
| Vancouver General Hospital- The Lung Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| St. Clare's Mercy Hospital | St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Firestone Institute for Respiratory Health | Hamilton | Ontario | L8N 4A6 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| The Ottawa Hospital-General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| St. Micheal's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| The Research Institute of the McGill University Health Centre (RI-MUHC) | Montreal | Quebec | H3H 2R9 | Canada |
| Hopital du Scaré-Coeur | Montreal | Quebec | H4J 1C5 | Canada |
| IUCP, Hôpital Laval | Québec | Quebec | G1V 4G5 | Canada |
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 30, 2024 | Dec 13, 2024 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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