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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06392776
Other study ID # Protocol ID 4373
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date December 2028

Study information

Verified date May 2024
Source Ottawa Hospital Research Institute
Contact Shawn Aaron, MD
Phone 6137378259
Email saaron@toh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 420
Est. completion date December 2028
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Early diagnosis and treatment
Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status. 12 weeks
Secondary Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT) The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 weeks minus the score on the day of randomization. A total change of - 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden. 12 weeks
Secondary Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing. The change will be expressed as the mean change in the FEV1 measurements at 12 weeks in comparison to the lung function measurements on the day of randomization. 12 weeks
Secondary 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. Differences between groups in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period. 12 weeks
Secondary Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes The baseline dyspnea index (BDI) is used to rate the severity of dyspnea at a single point in time and the transitional dyspnea index (TDI) is used to assess change in dyspnea at 12 weeks.
The differences between the experimental group and the control group TDI measured at 12 weeks.
12 weeks
Secondary Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI) The change in absenteeism and presenteeism will be assessed over the 12 week study period. Higher scores indicate greater impairment in work productivity and daily activities 12 weeks
Secondary Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 weeks minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status. 12 weeks
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