Clinical trial NCT06014840: The UCAP 2 Pilot Study
Official title: Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COPD
Asthma
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-08-28
Enrollment: 0
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 our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.


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 (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (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 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: Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
timeFrame: 12 weeks
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 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
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 groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Kathy Vandemheen
role: PRINCIPAL_INVESTIGATOR
References: