Clinical trial NCT06392776: Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
Official title: Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Asthma
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life.

The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals.

The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in a randomized, controlled clinical trial to determine whether early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by the primary care practitioner will improve their quality of life.


Eligibility criteria: Inclusion Criteria:

* Individuals at least 18 years old
* Individuals must be symptomatic with respiratory symptoms
* Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
* Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
* Individual must be able to perform pre and post bronchodilator spirometry to measure lung function

Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):

* Individuals who have undiagnosed airflow obstruction on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT.

Exclusion Criteria:

* Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
* Individuals currently under the care of a Respirologist.
* Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
* Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
* Individuals who are in the third trimester of pregnancy
* Individuals involved in another interventional trial

Primary outcomes:
measure: Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
timeFrame: 12 weeks
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 weeks
measure: Differences between the experimental group and the control group in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period.
timeFrame: 12 weeks
measure: Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
timeFrame: 12 weeks
measure: Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 12 weeks
measure: Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Hamilton Healthcare
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Shawn Aaron, MD
role: PRINCIPAL_INVESTIGATOR
References: