The UCAP 2 Pilot Study
Reason given: Study was never started, no participants were enrolled. The protocol was significantly changed and current described study was abandoned.
Key facts
- Where
- Ottawa, CanadaSee the site
Where in Canada
- Ottawa Hospital - General CampusOttawa, CanadaNo longer taking part
Trial details
- Who runs it
- Ottawa Hospital Research Institute
- Trial code
- NCT06014840
- Record updated
- 25 April 2024
- Original description
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.Read full original descriptionShow less
Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot Study
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.
Inclusion: 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: 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 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 currently under the care of a respirologist; Individuals who are in the third trimester of pregnancy; Individuals involved in another interventional trial.