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NCT07816718

Sustained Asthma Remission and Reduced Relapse Using a Comprehensive Management Strategy (SARRE-COMS)

Sponsor: Hana Serajeddini

View on ClinicalTrials.gov

Summary

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.

Official title: Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Pilot Randomized Control Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12-02

Completion Date

2028-12-30

Last Updated

2026-09-25

Healthy Volunteers

Conditions

Asthma (Diagnosis)

Interventions

OTHER

Comprehensive Biomarker-Guided Management Strategy

Participants will receive asthma management according to routine clinical practice in addition to a comprehensive biomarker-guided management strategy. Specialized biomarker assessments, including sputum cell analysis and imaging biomarkers, will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management. Treatment decisions may be informed by these specialized biomarker results throughout the 12-month study period.

OTHER

Standard of Care

Participants will receive asthma management according to routine clinical practice. Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions. Treatment decisions will be based on routinely available clinical information and standard clinical practice.

Inclusion Criteria: * Patient understands study procedures and is will to participate in the study as indicated by the patient's signature. * Provision of written, informed consent prior to any study specific procedures. * Males and females ≥ 18 years of age. * Diagnosis of severe asthma, as defined by ATS/ERS guidelines (requiring high-dose ICS plus second controller and/or OCS, or uncontrolled despite this therapy). * Eligible for initiation of biologic therapy for treatment of asthma or already on active treatment but not yet in a state of four-domain asthma remission. * Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include: * True sexual abstinence * A vasectomized sexual partner * Implanon® * Female sterilization by tubal occlusion * Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS) * Depo-Provera™ injections * Oral contraceptive * Evra Patch™ * Nuvaring™ * Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration. Exclusion Criteria: * Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis) that would meaningfully affect study endpoints per discretion of clinical team. * Patients with incomplete medical records. * Patients who are already in a state of asthma remission. * Patients with contraindications to PFT, sputum induction, CT imaging. * Patients who are pregnant or breastfeeding. * Patients who are unable or unwilling to comply with study procedures. * For the optional MRI procedure only: Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist). * In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the optional MRI or CT, such as severe claustrophobia. * Other contraindications to MRI.

Locations (1)

St. Joseph's Health Care London

London, Ontario, Canada