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

NCT07816718 | Not Yet Recruiting

• 1 other identifier: SJHC 005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma (Diagnosis)

Keywords

asthma; Severe Asthma; Biologic Therapy; Asthma Remission; Biomarker-Guided Management; FeNO

Outcome Measures

Primary Outcomes (5)

• Eligibility Rate

  Percentage of individuals screened for the study who meet the study eligibility criteria. The eligibility rate will be calculated as the number of screened individuals who meet the eligibility criteria divided by the total number of individuals screened, multiplied by 100

  During the study recruitment period

• Recruitment Rate

  The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.

  During the study recruitment period

• Enrolment Rate

  The enrolment rate will be calculated as the number of eligible individuals enrolled divided by the total number of eligible individuals approached for participation, multiplied by 100.

  During the study recruitment period

• Retention Rate

  The retention rate will be calculated as the number of participants who complete the Month 12 follow-up divided by the total number of randomized participants, multiplied by 100.

  Baseline(randomization) through Month 12

• Four-Domain Asthma Remission Rate in the Standard-of-Care Group

  Percentage of participants randomized to the standard-of-care (control) group who meet the protocol-defined criteria for 4-domain asthma remission at Month 12. The remission rate will be a corresponding confidence interval and will be used to inform sample size calculations for a future full-scale randomized controlled trial.

  Baseline(randomization) through Month 12

Secondary Outcomes (4)

• Study Assessment Completion Rate

  Baseline (randomization) through Month 12

• Adherence to Study Procedures

  Baseline (randomization) through Month 12

• Participant Acceptability of the Comprehensive Management Strategy

  Baseline (randomization) through Month 12

• Clinician Acceptability of the Comprehensive Management Strategy

  Baseline (randomization) through Month 12

Study Arms (2)

Comprehensive Management (Intervention)

EXPERIMENTAL

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.

Other: Comprehensive Biomarker-Guided Management Strategy

Standard of Care

ACTIVE COMPARATOR

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.

Other: Standard of Care

Interventions

Comprehensive Biomarker-Guided Management Strategy OTHER

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.

Comprehensive Management (Intervention)

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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™

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hana Serajeddini: lead
• St. Joseph's Health Care London: collaborator

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Asthma; Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Hana Serajeddini, MD, FRCPC

CONTACT

(519) 646-6100; hana.serajeddini@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will remain blinded to study arm allocation throughout the study. Clinicians are not blinded to study arm allocation because they will know whether specialized biomarker results are available to guide treatment decisions. Clinicians in the standard of care arm will be blinded to specialized biomarker results, while clinicians in the comprehensive management arm will have access to these results for clinical decision-making.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCPC Respirologist, Assistant Professor

Model Details: Participants will be randomized in a 1:1 ratio to either a standard of care (control) group or a comprehensive management (intervention) group. Participants in both groups will undergo the applicable study assessments. In the intervention group, clinicians will have access to specialized biomarker results and may use these results, together with routinely available clinical information, to inform treatment decisions. In the control group, clinicians will remain blinded to specialized research biomarker results, and treatment decisions will be based on standard clinical assessments and routine care. Participants will be followed for 12 months.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): December 2, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-05

Locations

CA (1)