[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655873":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":51,"studyPopulation":40,"armGroups":52,"interventions":65,"overallOfficials":40,"centralContacts":73,"locations":80,"responsibleParty":98,"collaborators":102,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":40,"enrollmentInfo":114,"targetDuration":40,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":130,"whyStopped":40,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":40},[9,13,16,19,23],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"Recruitment Rate","The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.",{"measure":17,"description":18,"timeFrame":12},"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.",{"measure":20,"description":21,"timeFrame":22},"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",{"measure":24,"description":25,"timeFrame":22},"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.",[27,31,34,37],{"measure":28,"description":29,"timeFrame":30},"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.","Baseline (randomization) through Month 12",{"measure":32,"description":33,"timeFrame":30},"Adherence to Study Procedures","Percentage of required study procedures completed according to the study protocol among enrolled participants.",{"measure":35,"description":36,"timeFrame":30},"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.",{"measure":38,"description":39,"timeFrame":30},"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.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":49},"SINGLE","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.",[50],"PARTICIPANT","Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.\n\nThis 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.\n\nFifty 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.\n\nParticipants 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.\n\nThe 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.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"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.",[58],"Other: Comprehensive Biomarker-Guided Management Strategy",{"label":60,"type":61,"description":62,"interventionNames":63},"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.",[64],"Other: Standard of Care",[66,70],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":40},"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.",[54],{"type":6,"name":60,"description":71,"armGroupLabels":72,"otherNames":40},"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.",[60],[74],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":79},"Hana Serajeddini, MD, FRCPC","CONTACT","(519) 646-6100","66288","hana.serajeddini@lhsc.on.ca",[81],{"facility":82,"status":40,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"St. Joseph's Health Care London","London","Ontario","N6A 4V2","Canada","CA",{"type":89,"coordinates":90},"Point",[91,92],-81.23304,42.98339,{"lat":92,"lon":91},[95],{"name":96,"role":76,"phone":77,"phoneExt":40,"email":97},"Tommy Li","zli3569@uwo.ca",{"type":99,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Hana Serajeddini","MD, FRCPC Respirologist, Assistant Professor",[103],{"name":82,"class":6},"100655873","sustained-asthma-remission-and-reduced-relapse-using-a-comprehensive-management-strategy-randomized-control-trial-100655873",false,"NCT07816718","Sustained Asthma Remission and Reduced Relapse Using a Comprehensive Management Strategy (SARRE-COMS)","Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Pilot Randomized Control Trial","SARRE-COMS","Inclusion Criteria:\n\n* Patient understands study procedures and is will to participate in the study as indicated by the patient's signature.\n* Provision of written, informed consent prior to any study specific procedures.\n* Males and females ≥ 18 years of age.\n* Diagnosis of severe asthma, as defined by ATS\u002FERS guidelines (requiring high-dose ICS plus second controller and\u002For OCS, or uncontrolled despite this therapy).\n* 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.\n* 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:\n* True sexual abstinence\n* A vasectomized sexual partner\n* Implanon®\n* Female sterilization by tubal occlusion\n* Effective intrauterine device (IUD)\u002Flevonogestrel intrauterine system (IUS)\n* Depo-Provera™ injections\n* Oral contraceptive\n* Evra Patch™\n* Nuvaring™\n* 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.\n\nExclusion Criteria:\n\n* Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis) that would meaningfully affect study endpoints per discretion of clinical team.\n* Patients with incomplete medical records.\n* Patients who are already in a state of asthma remission.\n* Patients with contraindications to PFT, sputum induction, CT imaging.\n* Patients who are pregnant or breastfeeding.\n* Patients who are unable or unwilling to comply with study procedures.\n* 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\u002For ear implants) (at the discretion of the MRI Technologist).\n* 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.\n* Other contraindications to MRI.","ALL","18 Years",{"count":115,"type":116},50,"ESTIMATED","INTERVENTIONAL",[119],"NA","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.\n\nThe main questions this pilot study aims to answer are:\n\nCan 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?\n\nResearchers 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.\n\nParticipants 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.",[122],"Asthma (Diagnosis)",[124,125,126,127,128,129],"asthma","Severe Asthma","Biologic Therapy","Asthma Remission","Biomarker-Guided Management","FeNO","NOT_YET_RECRUITING","2026-09-22",{"date":133,"type":134},"2026-09-25","ACTUAL",{"date":136,"type":116},"2026-12-02",{"date":138,"type":116},"2028-12-30",{"name":100,"class":6},1]