Comprehensive Management for Severe Asthma
(SARRE-COMS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this pilot clinical trial is to learn whether it is feasible to conduct a future larger trial of a comprehensive management strategy for adults with severe asthma who are starting biologic therapy.
The main questions this pilot study aims to answer are:
Can eligible participants be recruited and retained in the study? Can the study visits, tests, and other study procedures be successfully completed? Is the comprehensive management strategy acceptable to participants and clinicians? What proportion of participants receiving usual asthma care achieve asthma remission at 12 months?
Researchers will compare usual severe asthma care with a comprehensive management approach that uses specialized tests of airway inflammation and lung abnormalities to help doctors make treatment decisions.
Participants will be followed for 12 months. They will complete questionnaires, lung function tests, blood tests, and sputum testing. Clinically available CT scans obtained as part of usual care may also be used for study assessments. Participants may also choose to undergo optional research MRI scans.
Are You a Good Fit for This Trial?
This trial is for adults with severe asthma who are about to start biologic therapy. Participants should not have other major health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive asthma management according to routine clinical practice, with or without a comprehensive management strategy guided by specialized biomarker assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of asthma remission and relapse
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two approaches: standard asthma care versus a personalized management plan based on specialized tests (biomarkers) of airway inflammation and lung changes. Participants are randomly assigned to one group and followed for 12 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the comprehensive management arm will receive asthma management according to routine clinical practice in addition to a comprehensive management strategy. Specialized biomarker results from these specialized assessments will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management.
Participants randomized to the standard of care arm will receive severe asthma management according to routine clinical practice. Specialized research biomarker assessments will be performed; however, these results will not be disclosed to the treating clinician and will not be used to guide clinical management. Treatment decisions will be based on routinely available clinical information and standard clinical practice.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hana Serajeddini
Lead Sponsor
St. Joseph's Health Care London
Collaborator
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