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Undiagnosed COPD and Asthma Population Study (UCAP)

Primary Purpose

Asthma, COPD

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Treatment strategy using evidence-based guidelines for asthma or COPD
Smoking Cessation
Participant Education
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary
  • University of Alberta
  • Vancouver General Hospital- The Lung Centre
  • St. Boniface General Hospital
  • St. Clare's Mercy Hospital
  • Queen Elizabeth II Health Sciences Centre
  • Firestone Institute for Respiratory Health
  • Kingston General Hospital
  • London Health Sciences Centre
  • The Ottawa Hospital-General Campus
  • St. Micheal's Hospital
  • The Research Institute of the McGill University Health Centre (RI-MUHC)
  • Hopital du Scaré-Coeur
  • IUCP, Hôpital Laval
  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Enhanced Care

Standard of Care

Arm Description

Treatment strategy using evidence-based guidelines for asthma or COPD

Spirometry result sent to family MD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 8, 2017
Last Updated
March 21, 2023
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03148210
Brief Title
Undiagnosed COPD and Asthma Population Study (UCAP)
Official Title
A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
January 13, 2024 (Anticipated)
Study Completion Date
January 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Care
Arm Type
Active Comparator
Arm Description
Treatment strategy using evidence-based guidelines for asthma or COPD
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Spirometry result sent to family MD
Intervention Type
Drug
Intervention Name(s)
Treatment strategy using evidence-based guidelines for asthma or COPD
Intervention Description
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
Behavioral
Intervention Name(s)
Smoking Cessation
Intervention Description
Smoking cessation counselling by a qualified educator if currently smoking
Intervention Type
Behavioral
Intervention Name(s)
Participant Education
Intervention Description
Standardized education for asthma or COPD disease
Primary Outcome Measure Information:
Title
Annual rate of patient initiated healthcare utilization events for respiratory illness
Description
Number of visits for respiratory illnesses divided by the length of time in the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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; 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
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Vancouver General Hospital- The Lung Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
St. Clare's Mercy Hospital
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Firestone Institute for Respiratory Health
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
The Ottawa Hospital-General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
St. Micheal's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
The Research Institute of the McGill University Health Centre (RI-MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Facility Name
Hopital du Scaré-Coeur
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
IUCP, Hôpital Laval
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Undiagnosed COPD and Asthma Population Study (UCAP)

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