Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early diagnosis and treatment.
- Who it may be relevant to
- Registry conditions: COPD, Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Early diagnosis and treatment
Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner
Primary outcome measures
- Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). [Time frame: 12 weeks]
Secondary outcome measures (6)
- Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT) [Time frame: 12 weeks]
- Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing. [Time frame: 12 weeks]
- 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. [Time frame: 12 weeks]
- Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes [Time frame: 12 weeks]
- Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI) [Time frame: 12 weeks]
- Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Canada · 4 centers
- St. Joseph's Hamilton Healthcare — Hamilton
- Ottawa Hospital General Campus — Ottawa
- Royal University Hospital — Saskatoon
- Institut universitaire de cardiologie et de pneumologie de Québec — Québec
Identifiers
NCT: NCT06392776 · Protocol ID 4373