Clinical trial NCT03148210: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
COPD
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Annual rate of patient initiated healthcare utilization events for respiratory illness
timeFrame: 12 months
Secondary outcomes:
measure: Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.
timeFrame: 12 months
measure: Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
timeFrame: 12 months
measure: Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
timeFrame: 12 months
measure: Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
timeFrame: 12 months
measure: Smoking cessation rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital- The Lung Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Saint John's
country: Canada
facility: St. Clare's Mercy Hospital
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital-General Campus
state: Ontario
city: Toronto
country: Canada
facility: St. Micheal's Hospital
state: Ontario
city: Montreal
country: Canada
facility: The Research Institute of the McGill University Health Centre (RI-MUHC)
state: Quebec
city: Montréal
country: Canada
facility: Hopital du Scaré-Coeur
state: Quebec
city: Québec City
country: Canada
facility: IUCP, Hôpital Laval
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References: