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Recruiting NCT06392776

Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL

No phase Interventional COPD Asthma

For patients and families

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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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗