[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592123":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":11,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":11},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Spraying GM-CSF","EXPERIMENTAL",null,[13],"Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","GM-CSF (granulocyte-macrophage colony-stimulating factor)","Bronchoscopy under general anesthesia or sedation; The predetermined dose of recombinant GM-CSF was dissolved in normal saline. The diseased lung segments were located through bronchoscopy and the liquid medicine was sprayed.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Jiu-Wu Bai Doctor","CONTACT","13651602925","yv59@163.com",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Jiuwu Bai","associate chief physician","100592123","phase-2-local-spraying-of-gm-csf-via-bronchoscopy-in-the-treatment-of-autoimmune-pulmonary-alveolar-proteinosis-100592123",false,"NCT06989333","Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis","A Single-arm Clinical Study of Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis","aPAP and GMCSF","Inclusion Criteria:\n\n1. Age: 18 to 60 years old;\n2. A clear diagnosis of aPAP must meet at least one of the following diagnostic criteria:\n\n1\\) BALF appears \"milky white\"; Or cytological examination reveals a large amount of PAS-positive protein deposition; 2) HRCT shows typical \"paving stone-like changes\"; 3) Positive for serum GM-CSF antibody. 3. There are more than one of the following treatment indications: Symptoms such as progressive breathing difficulties, coughing, and shortness of breath after activity occur; 2) Without oxygen inhalation, PaO2 \\> 65 mmHg 3) Pulmonary function DLCO accounts for % of the predicted value, ranging from 60% to 80%, including the critical value.\n\n4\\. No other PAP specific treatments (such as WLL, inhaled GM-CSF, biological agents, etc.) have been received recently (for more than 4 weeks).\n\n5\\. Agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Secondary PAP (such as secondary to blood diseases, etc.);\n2. Patients with obvious pulmonary fibrosis, emphysema or irreversible lung function impairment;\n3. Patients in the acute exacerbation stage;\n4. Patients with other lung diseases (such as active pulmonary tuberculosis, bronchiectasis with purulent infection or other chronic infections; Have severe asthma, chronic bronchospasm, etc.\n5. Have a history of allergy to GM-CSF antibodies or related drug components;\n6. Patients who have participated in other clinical drug trials within the past three months;\n7. Patients who have experienced severe complications related to bronchoscopy or are intolerant to bronchoscopy;\n8. Concurrent with other serious cardiovascular and cerebrovascular diseases, hematological disorders, malignant tumors, etc.\n9. Pregnant or lactating women.","ALL","18 Years","80 Years",{"count":42,"type":43},10,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","This study aims to explore a new therapeutic approach: the feasibility, safety and preliminary efficacy of directly spraying GM-CSF into the airway through bronchoscopy for the treatment of aPAP.",[49],"Pulmonary Alveolar Proteinosis","NOT_YET_RECRUITING","2025-05-17",{"date":53,"type":54},"2025-05-25","ACTUAL",{"date":56,"type":43},"2025-07-01",{"date":58,"type":43},"2027-06-30",{"name":28,"class":6}]