Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL (UCAP2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; COPD
• Intervention / Treatment: Other: Early diagnosis and treatment

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shawn Aaron, MD; Phone Number: 6137378259; Email: saaron@toh.ca
• Study Contact Backup: Name: Kathy Vandemheen, MScN; Phone Number: 6137378259; Email: kvandemheen@toh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early diagnosis of previously undiagnosed asthma or COPD; On the day of randomization the participant will receive a copy of their interpreted spirometry report with a listed diagnosis. This report will be sent to their primary-care practitioner. In addition to the spirometry interpretation, the primary-care practitioner will be provided with a brief one-page guideline-based tool providing advice for pharmacologic and non-pharmacologic treatment of newly diagnosed asthma or COPD. The primary-care practitioner will be encouraged to see the participant as soon as possible to provide care. The participant will similarly be encouraged to make an appointment with the primary-care practitioner as soon as possible to access care for their condition	Other: Early diagnosis and treatment; Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner
No Intervention: Delayed diagnosis of previously undiagnosed asthma or COPD; At the 12 week visit, participants randomized to the delayed diagnosis will complete the trial outcome assessments. After completing the 12 week final trial assessments they will be seen by the study respirologist and treated for their newly diagnosed asthma or COPD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Differences between the experimental group and the control group in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.	Differences between groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.	12 weeks
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
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Shawn Aaron, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Protocol ID 4373

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No