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Behavioural Intervention

Early Diagnosis and Treatment for Asthma or COPD (UCAP2 Trial)

N/A

Recruiting

Led By Shawn Aaron, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals at least 18 years old

Individuals must be symptomatic with respiratory symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to identify Canadians with undiagnosed asthma or COPD using an online questionnaire. Those at risk will be invited to join a clinical trial to see if early diagnosis and treatment can improve

Who is the study for?

This trial is for Canadian adults with respiratory symptoms who suspect they might have asthma or COPD. They must score at least a 6% chance of having these conditions on an online questionnaire and be able to perform lung function tests. Only those without a prior diagnosis will be considered.

What is being tested?

The UCAP 2 TRIAL aims to see if early detection and treatment of undiagnosed asthma or COPD can improve patients' quality of life. Participants identified as at risk from an online survey are randomly chosen to receive primary care intervention.

What are the potential side effects?

Since the trial involves early diagnosis and standard treatments, side effects may include typical reactions to asthma or COPD medications such as inhalers, which can cause jitteriness, dry mouth, or sore throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am experiencing symptoms related to my breathing.

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I can do breathing tests before and after using a bronchodilator.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).

Secondary study objectives

Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes

Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)

Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early diagnosis of previously undiagnosed asthma or COPDExperimental Treatment1 Intervention

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

Group II: Delayed diagnosis of previously undiagnosed asthma or COPDActive Control1 Intervention

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.

0 / 3Eligibility criteria met