[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchiolitis-obliterans\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchiolitis-obliterans":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,73,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100370061","transpire-lung-injury-in-a-longitudinal-cohort-of-pediatric-hsct-patients-100370061",false,"NCT04098445","TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients","Inclusion Criteria:\n\n* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.\n\nExclusion Criteria:\n\n* Subjects over 24 years of age.","ALL","24 Years",{"count":18,"type":19},2000,"ESTIMATED","OBSERVATIONAL","Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.\n\nThis is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.",[23,24,25,26,27],"Hematopoietic Stem Cell Transplant (HSCT)","Diffuse Alveolar Hemorrhage","Thrombotic Microangiopathies","Interstitial Pneumonitis","Bronchiolitis Obliterans","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2021-09-08",{"date":36,"type":19},"2033-09",{"name":38,"class":39},"Children's Hospital Medical Center, Cincinnati","OTHER",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100510155","phase-2-belumosudil-for-bronchiolitis-obliterans-preventiontherapy-bebop-100510155","NCT05922761","BElumosudil for Bronchiolitis Obliterans Prevention\u002FTherapy (BEBOP)","An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria Cohort A:\n\n* Diagnosis of BOS after HCT using pulmonary function testing, per the NIH diagnostic criteria17 OR the Atypical BOS criteria33 3.1.2.1 NIH Diagnostic Criteria for BOS. All of the following must be met:\n\n  * FEV1\u002FVC \\\u003C 0.7 or \\\u003C5th percentile of predicted (FEV1 = Forced Expiratory Volume in 1 second; VC = Vital Capacity (either FVC, Forced Vital Capacity, or SVC, Slow Vital Capacity, whichever is greater)\n  * FEV1 \\\u003C75% of predicted with ≥ 10% absolute decline over less than 2 years. FEV1 should not correct to \\>75% of predicted with albuterol, and the absolute decline for the corrected values should still remain ≥ 10% over 2 years.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage).\n  * One of the two supporting features of BOS:\n\n    * i - Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR\n    * ii - Evidence of air trapping by PFTs: RV (Residual Volume) \\> 120% of predicted or RV\u002FTLC elevated outside the 90% confidence interval (RV\u002FTotal Lung Capacity).\n* Atypical Criteria for BOS:\n\n  * FEV1 \\\u003C80% of predicted with ≥ 10% absolute decline over the last 2 years or since transplant. The remote comparator can be an evaluation of PFTs done within 2 years of the PFTs assessment being evaluated to determine eligibility or the PFT assessment done prior to transplant.\n  * VC \\\u003C 80% of predicted.\n  * FEV1\u002FVC \\> 0.7.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage) or active non-infectious lung disease (such as interstitial lung disease) that explain spirometric changes or chest CT findings.\n\nInclusion Criteria for Cohort B:\n\n-Diagnosis of BOS-0p\n\n* Decline in FEV1 of 10% - 19% of predicted compared with pretransplant testing OR\n* Decline in predicted FEF25-75% (Forced Expiratory Flow between 25% and 75% of vital capacity) \\> 25%\n\nInclusion Criteria for Cohorts A and B:\n\n* Age ≥18 years. Belumosudil is currently being tested in pediatric populations and the safety and efficacy in pediatric patients have not yet been established. A protocol amendment to include pediatric patients will be considered once safety in pediatric patients is established.\n* ECOG performance status ≤2 (Karnofsky ≥ 60%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * WBC ≥ 3,000\u002FμL\n  * Absolute neutrophil count ≥ 1,500\u002F μL\n  * Platelets ≥ 50,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* No evidence of relapsed malignancy at the time of enrollment. Formal re-staging is not required for trial entry.\n* All females of childbearing potential must have a negative serum or urine pregnancy test \\\u003C 7 days before study drug administration.\n* The ability to understand and willingness to sign a written consent document.\n\nExclusion Criteria for Cohorts A and B:\n\n* Participants who have received prior therapy specifically for BOS. Therapy for cGVHD in the absence of BOS is permissible.\n* Prior exposure to belumosudil.\n* Participants who are receiving any other investigational immunosuppressive agents for cGVHD.\n* Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persistent fever without signs or symptoms will not be interpreted as an active uncontrolled infection.\n* Known human immunodeficiency virus infection. Interactions between belumosudil and anti-retroviral agents have not been established.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.","18 Years",{"count":50,"type":19},45,"INTERVENTIONAL",[53],"PHASE2","The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).\n\nThe name of the study drugs involved in this study are:\n\n* Belumosudil (an immunotherapy)\n* Fluticasone (an intranasal corticosteroid)\n* Azithromycin (an antibiotic)\n* Montelukast (a leukotriene receptor antagonist)\n* Prednisone (a corticosteroid)",[56,27,57,58],"Bronchiolitis Obliterans Syndrome","Lung Diseases","Chronic Graft Versus Host Disease",[56,27,60,61,62,58],"Lung Disease","Allogeneic hematopoietic stem cell transplant","HSCT","2026-06-08",{"date":65,"type":32},"2026-06-10",{"date":67,"type":32},"2024-05-31",{"date":69,"type":19},"2027-12-31",{"name":71,"class":39},"Dana-Farber Cancer Institute",6,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100408903","evaluating-clonogenic-epithelial-cell-populations-in-patients-with-bronchiolitis-obliterans-syndrome-100408903","NCT04604522","Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome","Inclusion Criteria:\n\n* Allo-HCT recipients undergoing a bronchoscopy at MDACC who consent to undergoing study airway brushings in addition to clinically indicated bronchoscopic procedures (e.g. bronchoalveolar lavage)\n\n  * 5 patients with advanced BOS - forced expiratory volume in one second (FEV1) =\\\u003C 75% predicted and meeting other National Institutes of Health (NIH) criteria (FEV1\u002Fforced vital capacity \\[FVC\\] ratio 0.7, presence of air trapping or graft versus host disease \\[GVHD\\] of another organ)\n  * 5 patient with early BOS - at least 10% decline in FEV1 from baseline values, with FEV1 \\>= 75% predicted, and 1 high-risk feature:\n\n    * Active systemic chronic GVHD with new early airflow obstruction OR\n    * Respiratory viral infection in last three months with resolution of viral symptoms but new airflow obstruction\n  * 3 patients with no pulmonary impairment (FEV1 within 5% of baseline values)\n* Lung allograft recipients undergoing a bronchoscopy at Houston Methodist who consent to undergoing study airway brushing sin addition to clinically indicated bronchoscopy procedures\n\n  * 5 patients with BOS Stage 2 or higher (\\>= 35% decline in FEV1 from baseline values)\n  * 5 patient with BOS Stage 0p or 1 (10-35% decline in FEV1 from baseline values)\n  * 3 patients undergoing screening bronchoscopy without decline in FEV1\n  * patients with undiagnosed lung cancer and chronic obstructive pulmonary disease diagnosed by pulmonary function testing (FEV1\u002FFVC less than the lower limit of normal with \\>20 pack-year history of smoking)\n\nExclusion Criteria:\n\n* Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing\n* Patient unwilling to give consent for study airway brushings",{"count":80,"type":19},15,"This study investigates a type of cell, called abnormal clonogenic epithelial cells, in patients with bronchiolitis obliterans syndrome who have had an donor stem cell transplant or a lung transplant. Learning more about clonogenic cells in these patients may help doctors to detect signs of bronchiolitis obliterans syndrome earlier in future patients.",[27],"2026-03-09",{"date":85,"type":32},"2026-03-11",{"date":87,"type":32},"2020-08-27",{"date":89,"type":19},"2026-03-31",{"name":91,"class":39},"M.D. Anderson Cancer Center",1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":51,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":92},"100526911","bronchial-epithelium-of-children-with-post-infectious-bronchiolitis-obliterans-100526911","NCT06140901","Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans","Morphological and Functional Pilot Study of the Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans","e-PIBO","Inclusion Criteria:\n\n1. Children from 1 month to 6 years hospitalized at the Timone Enfant University Hospital\n2. Diagnosis of an adenovirus or rhinovirus respiratory infection confirmed on a nasal swab, made upon arrival as part of the child's initial care\n3. Consent form read, understood, approved and signed by parents before any study procedure\n4. Affiliation to a social security scheme or beneficiary of such a scheme\n\nThe inclusion criteria for children who were not hospitalized when diagnosed with an adenovirus and rhinovirus respiratory infection at the Timone Enfant University Hospital are:\n\n1. Children from 1 month to 6 years old transferred to the Timone Enfant University Hospital\n2. Show the following signs:\n\n   has. Clinical: clinical signs persist 6 weeks after a viral infection: tachypnea, wheezing and\u002For persistent hypoxemia b. Scan: mosaic appearance +\u002F- bronchiectasis, atelectasis vs. +\u002F- EFR if performed: obstructive ventilatory disorder not or only slightly reversible after bronchodilators\n3. Consent form read, understood, approved and signed by parents before any study procedure\n4. Affiliation to a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n1. Refusal of participation in the study by the family will be a reason for non-inclusion, as well as in the absence of parental authority.\n2. The existence of an underlying chronic pulmonary pathology (e.g. cystic fibrosis, ciliary dyskinesia).\n3. A coagulation pathology.","1 Month","6 Years",{"count":104,"type":19},450,[106],"NA","Bronchiolitis obliterans (BO) is an irreversible chronic obstructive pulmonary pathology leading to obstruction and\u002For obliteration of the small airways. In children, the most common form of BO occurs following a serious lower respiratory tract infection. This is a rare complication; the incidence is unknown. The diagnosis, often late, is made on clinical, spirometric and radiological arguments. The pathophysiology would be linked to damage to the airway epithelium. PIBO is most commonly associated with adenovirus (ADV) infection (serotypes 3, 7, 11 and 21) but also other viruses such as rhinovirus (RV). The treatment of PIBO is not clearly established, it remains empirical.\n\nThe research hypothesis is that the morphology of the nasal epithelium of children with ADV or RV infection is different for those progressing to PIBO. The main objective of the proposed observational study is to characterize damage to the respiratory epithelium in these children.\n\nThis is a single-center prospective longitudinal study (AP-HM), in children aged 1 month to 6 years, comparing children hospitalized for lower respiratory infection by ADV or RV progressing or not to PIBO. All children included will have a nasal swab and brushing on D0. Children developing PIBO will have nasal brushing with bronchial endoscopy with bronchial biopsies and bronchoalveolar washing at the time of PIBO diagnosis and again at M6 in case of partial response to treatment.\n\nThis is therefore a pilot study aimed at defining damage to the respiratory epithelium in children with PIBO following an ADV or RV infection and the role of respiratory epithelial cells in PIBO.",[27],[110,111],"children","post infectious","2025-04-23",{"date":114,"type":32},"2025-04-25",{"date":116,"type":32},"2023-12-04",{"date":118,"type":19},"2026-11",{"name":120,"class":121},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV"]