Asthma (Diagnosis)SARRE-COMSNCT07816718
Sustained Asthma Remission and Reduced Relapse Using a Comprehensive Management Strategy (SARRE-COMS)
A study testing Comprehensive Biomarker-Guided Management Strategy in people with Asthma (Diagnosis), run by Hana Serajeddini at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Comprehensive Biomarker-Guided Management Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Joseph's Health Care London
London, Ontario, N6A 4V2
Tommy Li, (519) 646-6100, zli3569@uwo.ca
About this study
Official title: Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Pilot Randomized Control 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:
Read more
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.
Read the detailed description
Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.
This pilot randomized controlled trial will assess the feasibility of conducting a future full-scale randomized controlled trial evaluating whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The future full-scale trial will also evaluate whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care.
Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to specialized research biomarker results.
Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, and sputum cell analysis. Clinically available computed tomography (CT) imaging obtained as part of usual care may also be used for study assessments. Participants who consent to the optional magnetic resonance imaging (MRI) component may undergo research MRI assessments.
The findings from this pilot study will provide feasibility data and preliminary information regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and will inform the design of the future full-scale randomized controlled trial.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Comprehensive Biomarker-Guided Management Strategy, Standard of Care
- Keywords
- asthma, Severe Asthma, Biologic Therapy, Asthma Remission, Biomarker-Guided Management, FeNO
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Biomarker-Guided Management StrategyOther
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline(randomization) through Month 12
Secondary outcomes (4)
Study Assessment Completion Rate
Percentage of scheduled study assessments completed by participants. The assessment completion rate will be calculated as the number of completed required study assessments divided by the total number of scheduled required study assessments, multiplied by 100.
Measured: Baseline (randomization) through Month 12
Adherence to Study Procedures
Percentage of required study procedures completed according to the study protocol among enrolled participants.
Measured: Baseline (randomization) through Month 12
Participant Acceptability of the Comprehensive Management Strategy
Acceptability and satisfaction with the comprehensive biomarker-guided management strategy will be assessed among participants using an Acceptability and Satisfaction Questionnaire.
Measured: Baseline (randomization) through Month 12
Clinician Acceptability of the Comprehensive Management Strategy
Acceptability and satisfaction with the comprehensive biomarker-guided management strategy will be assessed among participating clinicians using an Acceptability and Satisfaction Questionnaire.
Measured: Baseline (randomization) through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start2 Dec 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hana Serajeddini
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Responsible party
- Sponsor-investigator, Hana Serajeddini, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816718
- Sponsor's protocol ID
- SJHC 005
- Acronym
- SARRE-COMS
- Status last verified
- May 2026
- First submitted
- 8 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team has not yet determined whether IPD will be shared with other researchers. Any future data-sharing plans will be developed in accordance with applicable ethics approvals, participant consent, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07816718
- Acronym / sponsor ID
- SARRE-COMS / SJHC 005
- Conditions
- Asthma (Diagnosis)
- Keywords
- asthma, Severe Asthma, Biologic Therapy, Asthma Remission, Biomarker-Guided Management, FeNO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hana SerajeddiniUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Study start
- 2 Dec 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.
This pilot randomized controlled trial will assess the feasibility of conducting a future full-scale randomized controlled trial evaluating whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The future full-scale trial will also evaluate whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care.
Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to specialized research biomarker results.
Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, and sputum cell analysis. Clinically available computed tomography (CT) imaging obtained as part of usual care may also be used for study assessments. Participants who consent to the optional magnetic resonance imaging (MRI) component may undergo research MRI assessments.
The findings from this pilot study will provide feasibility data and preliminary information regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and will inform the design of the future full-scale randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Management (Intervention) | Experimental | Other: Comprehensive Biomarker-Guided Management StrategyParticipants 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. |
| Standard of Care | Active comparator | Other: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Biomarker-Guided Management StrategyParticipants 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 | Comprehensive Management (Intervention) |
| Standard of CareParticipants 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. | Other | Standard of Care |
Primary outcome
Eligibility Rate
Time frame: During the study recruitment period
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
Recruitment Rate
Time frame: During the study recruitment period
The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.
Enrolment Rate
Time frame: During the study recruitment period
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.
Retention Rate
Time frame: Baseline(randomization) through Month 12
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.
Four-Domain Asthma Remission Rate in the Standard-of-Care Group
Time frame: Baseline(randomization) through Month 12
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.
4 secondary outcomes
Study Assessment Completion Rate
Time frame: Baseline (randomization) through Month 12
Adherence to Study Procedures
Time frame: Baseline (randomization) through Month 12
Participant Acceptability of the Comprehensive Management Strategy
Time frame: Baseline (randomization) through Month 12
Clinician Acceptability of the Comprehensive Management Strategy
Time frame: Baseline (randomization) through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided. The study team has not yet determined whether IPD will be shared with other researchers. Any future data-sharing plans will be developed in accordance with applicable ethics approvals, participant consent, and institutional policies.
Related trials for Asthma (Diagnosis)
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Biomarker-Guided Management Strategy in people with Asthma (Diagnosis), run by Hana Serajeddini at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hana Serajeddini, MD, FRCPC ((519) 646-6100 ext. 66288, hana.serajeddini@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility Rate (time frame: During the study recruitment period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.