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

Asthma Clinical Trial

— UCAP2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392776
• Other study ID #: Protocol ID 4373
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• COPD

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