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Trial record 1 of 1 for:    UCAP
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Undiagnosed COPD and Asthma Population Study (UCAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148210
Recruitment Status : Enrolling by invitation
First Posted : May 10, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Asthma COPD Drug: Treatment strategy using evidence-based guidelines for asthma or COPD Behavioral: Smoking Cessation Behavioral: Participant Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Enhanced Care
Treatment strategy using evidence-based guidelines for asthma or COPD
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

Behavioral: Participant Education
Standardized education for asthma or COPD disease

Placebo Comparator: Standard of Care
Spirometry result sent to family MD
Behavioral: Smoking Cessation
Smoking cessation counselling by a qualified educator if currently smoking




Primary Outcome Measures :
  1. Annual rate of patient initiated healthcare utilization events for respiratory illness [ Time Frame: 12 months ]
    Number of visits for respiratory illnesses divided by the length of time in the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148210


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Vancouver General Hospital- The Lung Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
St. Clare's Mercy Hospital
Saint John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M6M2
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Michael Garron Hospital/Toronto East Health Network
Toronto, Ontario, Canada, M4C 3E7
St. Micheal's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Hopital du Scaré-Coeur
Montréal, Quebec, Canada, H4J 1C5
IUCP, Hôpital Laval
Québec City, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03148210    
Other Study ID Numbers: 20170182-01H
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases