protocolSection identificationModule nctId: NCT06288516, orgStudyIdInfo id: 7484, briefTitle: BenRalizumab Effect on Airway Remodeling in Severe asTHma, acronym: BREATH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Aristotle University Of Thessaloniki, class: OTHER, collaborators name: Pulmonary Clinic, Aristotle University of Thessaloniki, Greece, collaborators name: Pulmonary Clinic, University of Ioannina, collaborators name: Pulmonary Clinic, Democritus University of Thrace, collaborators name: 2nd Pulmonary Clinic, Kapodistrian University of Athens, collaborators name: University Hospital of Crete, collaborators name: Pulmonary and Respiratory Failure Department, National and Kapodistrian University of Athens, collaborators name: University Hospital of Patras, descriptionModule briefSummary: Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment.Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis.Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?, conditionsModule conditions: Asthma; Eosinophilic, conditions: Airway Remodeling, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Benralizumab (30mg) administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Benralizumab 30 mg/ml, outcomesModule primaryOutcomes measure: Change in sub-basement membrane thickness, primaryOutcomes measure: Change in airway smooth muscle area, primaryOutcomes measure: Change in airway smooth muscle layer thickness, primaryOutcomes measure: Change in submucosal eosinophil number, primaryOutcomes measure: Change in epithelial integrity, primaryOutcomes measure: Change in collagen thickness, secondaryOutcomes measure: Change of cytokine and protein levels, secondaryOutcomes measure: Change in exacerbation rate, secondaryOutcomes measure: Change in blood eosinophil levels, secondaryOutcomes measure: dentification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital, status: RECRUITING, city: Thessaloniki, zip: 57010, country: Greece, contacts name: Kalliopi Domvri, Dr, role: CONTACT, phone: 00302313307258, email: kdomvrid@auth.gr, contacts name: Konstantinos Porpodis, Prof, role: CONTACT, phone: 00302313307179, email: kporpodis@yahoo.gr, geoPoint lat: 40.64361, lon: 22.93086, hasResults: False