[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586578":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":30,"collaborators":7,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":7,"enrollmentInfo":43,"targetDuration":7,"studyType":46,"phases":7,"briefSummary":47,"conditions":48,"keywords":51,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Stefano Ghio, MD","CONTACT","+39 0382503460","s.ghio@smatteo.pv.it",[15],{"facility":16,"status":17,"city":18,"state":18,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"Fondazione IRCCS Policlinico San Matteo","RECRUITING","Pavia","27100","Italy","IT",{"type":23,"coordinates":24},"Point",[25,26],9.15917,45.19205,{"lat":26,"lon":25},[29],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Stefano Ghio","MD","100586578","proof-of-concept-study-on-the-efficacy-of-inhalatory-targeted-imatinib-nanoformulations-in-pulmonary-hypertension-and-post-inflammatory-fibrosis-100586578",false,"NCT06917196","PROOF OF CONCEPT STUDY ON THE EFFICACY OF INHALATORY TARGETED IMATINIB NANOFORMULATIONS IN PULMONARY HYPERTENSION AND POST-INFLAMMATORY FIBROSIS.","PROMPTLY","Inclusion Criteria:\n\n* Patients aged ≥ 18 years diagnosed with fibrosing lung disease, obliterative bronchiolitis, or PAH, who are candidates for or have undergone lung transplantation.\n* Obtaining informed consent for all patients enrolled prospectively and all those enrolled retrospectively at their first clinical occurrence at our center.\n\nExclusion Criteria:\n\n* Suspected or confirmed diagnosis of pulmonary neoplastic disease.","ALL","18 Years",{"count":44,"type":45},16,"ESTIMATED","OBSERVATIONAL","The PROMPTLY study is a proof-of-concept research project evaluating the efficacy of XHALIP, an innovative inhalable formulation of Imatinib, in treating pulmonary arterial hypertension (PAH) and post-inflammatory fibrosing lung diseases (LFD).\n\nMain Objective To demonstrate the ability of XHALIP to improve the prognosis of PAH and LFD by reducing pulmonary fibrosis and vascular remodeling.\n\nKey Research Questions Is XHALIP effectively absorbed by pathological lung cells? Does it have a beneficial biological effect on cell proliferation and extracellular matrix deposition? Study Plan Preclinical phase: In vitro tests on cells obtained from patients with PAH and LFD.\n\nAbsorption and distribution analysis: In vitro lung tissue models to assess drug penetration and effectiveness.\n\nBiological activity assessment: Evaluating XHALIP's ability to inhibit epithelial-mesenchymal transition and cell proliferation.\n\nParticipants Patients aged ≥ 18 years diagnosed with PAH or LFD, either candidates for or recipients of lung transplantation.\n\nBiological samples (bronchoalveolar lavage and explanted lung tissues). Methodology Confocal microscopy and flow cytometry to analyze absorption. RT-PCR and Western Blot to assess biological efficacy. Alveolo-capillary models to test drug release and distribution. The study aims to translate preclinical findings into a potential future clinical trial for the development of XHALIP as a novel inhalation-based therapeutic strategy for rare lung diseases.",[49,50],"Pulmonary Arterial Hypertension (PAH)","Lung Fibrosis Interstitial",[52,53,54,55,56,57],"PAH","LFD","Pulmonary arterial hypertension","lung fibrosis desease","XHALIP","imatinib","2025-03-31",{"date":60,"type":61},"2025-04-08","ACTUAL",{"date":63,"type":61},"2023-12-04",{"date":65,"type":45},"2026-06-04",{"name":5,"class":6},1]