北京JNJ-95597528注射液II期临床试验-JNJ-95597528治疗控制不佳中重度哮喘试验参与者的研究( READY-BREATHE )

登记号	CTR20263295	试验状态	进行中
申请人联系人	张瑞琪	首次公示信息日期	2026-08-27
申请人名称	强生（中国）投资有限公司

登记号	CTR20263295
相关登记号	暂无
药物名称	JNJ-95597528注射液
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	哮喘
试验专业题目	一项评价JNJ-95597528治疗控制不佳中重度哮喘成人试验参与者的疗效和安全性的IIb期、多中心、随机、双盲、安慰剂对照、剂量范围探索试验
试验通俗题目	JNJ-95597528治疗控制不佳中重度哮喘试验参与者的研究( READY-BREATHE )
试验方案编号	95597528ASH2001	方案最新版本号	原始版本
版本日期:	2026-06-10	方案是否为联合用药	否

申请人名称	[["强生（中国）投资有限公司"]]
联系人姓名	张瑞琪	联系人座机	021-22013000	联系人手机号
联系人Email	Rzhan120@its.jnj.com	联系人邮政地址	上海市-上海市-徐汇区桂箐路65号新研大厦6楼	联系人邮编	200233

本研究的目的是评估JNJ-95597528与安慰剂相比治疗中重度哮喘（影响肺部气道的长期疾病）成人试验参与者的疗效

试验分类	安全性和有效性	试验分期	II期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 85岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["签署知情同意书时年龄≥18 至85 岁（或至少为试验开展地区认可的法定年龄）"],["根据筛选或基线时进行的体格检查、病史和生命体征检查，判定病情稳定"],["哮喘诊断：根据2025 年全球哮喘防治倡议（GINA）指南，在筛选访视前至少12 个月内，有医生诊断并记录的哮喘"],["急性发作史：试验参与者在筛选访视前1 年内必须发生过至少1 次急性发作，定义如下：因哮喘加重而接受全身性激素治疗（口服或胃肠外给药）至少3 天，或因哮喘加重而住院治疗"],["筛选或基线访视时，支气管扩张剂使用前的FEV1 占预测值＞40%至＜90%"],["根据研究方案中规定的标准，，在基线访视时根据GINA 2025 指南确认存在可变呼气气流（满足以下1 项或多项）"],["吸入性激素：根据GINA 2025 指南，在筛选访视前已接受处方中剂量或高剂量吸入性激素（ICS）治疗至少1 年，且接受稳定的中剂量或高剂量ICS 治疗至少3 个月"],["其他控制药物：根据GINA 2025 指南，除接受ICS 治疗外，试验参与者必须在筛选前接受至少1 种其他哮喘维持控制药物的稳定剂量给药至少3 个月（例如LABA、LAMA[可与ICS 混合于同一吸入器中或分开放入不同吸入器]、LTRA）"],["筛选期间试验参与者需证明其在填写哮喘日志及服用背景治疗药物方面的依从性≥70%。定义为：在随机化前的最后14 天中，在任意10 个早晨以及任意10 个晚上填写了哮喘日志，且在随机化前的最后14 天中，至少有10 天对按计划规律服用哮喘药物的回答为“是”"],["在筛选访视和基线访视时ACQ-5 评分≥1.5"],["筛选时体质指数在18 至40 kg/m2（含）之间，且体重≥40 kg"],["根据筛选或基线时进行的体格检查、病史和生命体征检查，判定病情稳定"],["筛选时进行的临床实验室检查显示试验参与者病情稳定"],["如果试验参与者正在接受过敏原特异性免疫治疗，则必须在筛选访视前接受稳定剂量给药至少2 个月，且治疗期间预期不会发生变化。这些治疗不应与临床试验用药品（IP）在同一天给药"],["入组本试验期间和试验药物末次给药后13 个月（约395天）内，女性试验参与者必须：na. 不得处于妊娠期、哺乳期，也不得计划妊娠。nb. 同意不捐献配子（即卵子）或冷冻配子以备将来用于辅助生殖。nc. 满足以下两项条件之一：1) 无生育能力 或 2) 有生育能力且：a) 筛选时高灵敏度（例如β-hCG）妊娠试验结果为阴性，第0 周试验药物给药前尿妊娠试验结果为阴性，并且同意接受后续妊娠试验。b) 采取至少1 种高效避孕方法。nn入组本试验期间和试验药物末次给药后至少13 个月（约395天）内，男性试验参与者必须：nd. 不得有生育计划ne. 同意不出于辅助生殖目的而捐献精子或冷冻精子以备将来使用。nf. 接受过输精管切除术n或n未行输精管切除术的男性试验参与者必须同意在与有生育能力的女性发生性行为时使用屏障避孕法。还须告知男性试验参与者其女性伴侣使用高效避孕方法的好处"],["试验参与者必须签署知情同意书，表明其理解试验的目的和所需程序，且愿意参加研究"],["如果试验参与者同意提供用于研究的可选DNA 样本（在当地法规允许的条件下）或进行可选的高分辨率CT（HRCT）影像检查，则试验参与者必须签署相应子研究的单独ICF。拒绝提供关于采集可选DNA 样本或进行HRCT 影像检查的知情同意书不会导致试验参与者被排除出研究"],["愿意并能够遵循计划的访视安排、治疗计划、实验室检查、生活方式限制事项以及其他试验程序"]]
排除标准	[["存在未受控制的重大肾脏、心脏、血管、肺部（哮喘除外）、胃肠道、内分泌、神经、血液、风湿、精神或代谢障碍病史，且经研究者判断，试验参与者不适合参加试验"],["除哮喘外的任何具有临床意义的肺部疾病，或除哮喘外的任何与外周嗜酸粒细胞计数升高相关的肺部或全身性疾病"],["经研究者判断，筛选访视时获得的安全性评估中存在任何具有临床意义的结果，可能影响试验数据的解读或试验参与者在研究中的安全性"],["曾接受器官移植"],["既往接受过JNJ-95597528 治疗，或疑似或已知对JNJ-95597528 或其辅料发生过超敏反应或不耐受"],["未达到主要疗效终点（16 周内无应答）或发生过与抑制IL-13、IL-4Rα 和IL-4 信号传递的药物有关的需要停药的不良事件"],["在筛选前8 周内接受过重大手术，或无法从手术中完全康复，或在预计参加研究的时间段内有此类手术安排"],["在筛选访视前2 周内发生以下任一事件的试验参与者：a. 因哮喘加重而接受全身性激素（口服或胃肠外给药）治疗 b. 因哮喘加重而住院治疗或进行紧急医疗访视"],["在发生符合条件的哮喘急性发作事件时开始进行抗炎缓解治疗且在开始抗炎缓解治疗后未出现其他哮喘急性发作事件的试验参与者"],["存在任何CT 扫描的绝对禁忌症（仅适用于同意参加影像检查子研究的试验参与者）"],["当前吸烟者或吸烟史≥20 包年的既往吸烟者。既往吸烟者必须在筛选访视前已戒烟至少6 个月。这包括使用雾化产品和电子烟的试验参与者"],["筛选前1 年内有物质滥用史或酒精滥用史"],["正在使用GLP-1 的个体必须接受稳定剂量的GLP-1 治疗，且在筛选访视前12 周内体重达到稳定状态（定义为体重变化≤5%）"],["有慢性或复发性感染性疾病史，包括但不限于慢性肾脏感染、慢性胸部感染、复发性尿路感染、真菌感染、分枝杆菌感染，或开放性伤口、伤口渗液、皮肤伤口感染或溃疡"],["筛选访视前12 个月内需要接受治疗的结核病"],["诊断为活动性寄生虫感染或有寄生虫感染高风险，除非在随机化前接受了抗蠕虫治疗"],["存在已知或疑似免疫缺陷，包括侵袭性机会性感染史，或存在频率异常或持续时间延长的复发性感染（尽管感染最终消退），提示免疫功能受损（经研究者判定）"],["筛选前8 周内存在严重感染，或因感染住院治疗或接受过静脉抗生素治疗"],["筛选时HBV 或HCV 感染检测呈阳性或已知肝硬化"],["有HIV 抗体阳性、HIV 检测阳性史或筛选时HIV 检测结果呈阳性"],["目前患有恶性肿瘤或筛选前5 年内有恶性肿瘤史"],["有淋巴细胞增生性疾病史，包括淋巴瘤；有意义不明的单克隆丙种球蛋白病史；或提示可能存在淋巴细胞增生性疾病的体征和症状，如淋巴结病或脾肿大"],["根据研究方案中的规定，在指定时间点内接受过任何指定治疗"],["同时参加另一项涉及临床试验用药品的临床试验"],["研究者或试验中心的雇员（直接参与本拟定试验，或参与由本研究的研究者或研究中心负责的其他试验），以及这些雇员或研究者的家属"],["研究者认为试验参与者存在的病症会导致参加本研究不符合试验参与者最佳利益（例如会损害健康）或者可能妨碍、限制或混淆研究方案规定的评估"],["依法院或政府命令居住在特定机构，或被视为弱势群体（例如，受到保护或被剥夺自由的成年人、无法给予知情同意或处于紧急情况的成人）"]]

试验药	[["中文通用名:JNJ-95597528 英文通用名:JNJ-95597528 商品名称:NA","剂型:皮下注射 规格:150mg/ml(1.0ml/瓶) 用法用量:第1组：JNJ-95597528，剂量1将在第0周、第2周、第12周、第24周和第36周给予。第2组：NJ-95597528，剂量2将在第0周给予，随后剂量3在第12周、第24周和第36周给予。第3组：NJ-95597528，剂量4将在第0周给予，随后剂量5在第12周、第24周和第36周给予 用药时程:试验参与者将根据方案规定时程接受特定剂量JNJ-95597528直至第36周"]] 序号 名称 用法
对照药	[["中文通用名:匹配安慰剂（蔗糖、L-精氨酸盐酸盐、L-组氨酸、L-组氨酸盐酸盐、聚山梨酯80、注射用水） 英文通用名:Placebo 商品名称:NA","剂型:皮下注射 规格:1ml/瓶 用法用量:试验参与者将在第0周、第2周、第12周、第24周和第36周接受匹配剂量的安慰剂 用药时程:试验参与者将接受匹配剂量的安慰剂直至第36周"]] 序号 名称 用法

主要终点指标及评价时间	[["截至第48周哮喘急性发作次数","至第48周","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["从第0周至第48周，至首次哮喘急性发作事件发生时间","从第0周至第48周","有效性指标"],["第2、12、24 和48周时支气管扩张剂使用n前第一秒用力呼气容积（FEV1）较基线的变化","基线，第2、12、24 和48 周","有效性指标"],["第2、12、24 和48周时呼出气一氧化氮（FeNO）较基线的变化","基线，第2、12、24 和48 周","有效性指标"],["第48周哮喘控制问卷，5项（ACQ-5）较基线的变化","基线，第48周","有效性指标"],["第48周时7天平均哮喘日志评分较基线的变化","基线，第48周","有效性指标"],["发生不良事件（AE）和严重不良事件（SAE）的受试者数量","至90周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	杨汀	学位	医学博士	职称	主任医师
	电话	13651380809	Email	dryangting@qq.com	邮政地址	北京市-北京市-朝阳区樱花园东街2号
	邮编	100029	单位名称	中日友好医院

[["中日友好医院","杨汀","中国","北京市","北京市"],["山西白求恩医院","李晓晨","中国","山西省","太原市"],["甘肃省人民医院","张宏","中国","甘肃省","兰州市"],["常州市第二人民医院","杨明夏","中国","江苏省","常州市"],["广州医科大学第三医院","魏立平","中国","广东省","广州市"],["成都市第五人民医院","刘晓","中国","四川省","成都市"],["安徽胸科医院","方浩徽","中国","安徽省","合肥市"],["上海市第一人民医院","张旻","中国","上海市","上海市"],["扬州市第一人民医院","吴峰","中国","江苏省","扬州市"],["温州医科大学附属第二医院","吴立琴","中国","浙江省","温州市"],["内蒙古自治区人民医院","包萨日娜","中国","内蒙古自治区","呼和浩特市"],["济宁市第一人民医院","边翠霞","中国","山东省","济宁市"],["宁波市医疗中心李惠利医院","姜静波","中国","浙江省","宁波市"],["Instituto de Medicina Respiratoria IMER","Alexis Cazaux","阿根廷","Córdoba","Córdoba"],["Investigaciones en Patologias Respiratorias","Ana Stok","阿根廷","Tucumán","San Miguel de Tucumán"],["Fundacion Scherbovsky","Pablo Saez Scherbovsky","阿根廷","Mendoza","Capital"],["IBAMEDICA","Martin Maillo","阿根廷","Santa Fe","Santa Fe"],["Instituto de Especialidades de la Salud Rosario - Clinical del Torax","Ledit Ardusso","阿根廷","Santa Fe","Rosario"],["Instituto Ave Pulmo","Luis Wehbe","阿根廷","Buenos Aires","Mar del Plata"],["INAER - Investigación en Alergias y Enfermedades Respiratorias","Anahí Yanez","阿根廷","Buenos Aires","Buenos Aires"],["ARCIS Salud SRL Aprillus asistencia e investigacion","Pablo Alejandro Mannucci Walter","阿根廷","Buenos Aires","Buenos Aires"],["INSARES S.A.","Carlos Elias","阿根廷","Mendoza","Mendoza"],["IDIM Instituto de Diagnostico e Investigaciones Metabolicas","Ricardo del Olmo","阿根廷","Cdad Autonoma de Buenos Aires","Buenos Aires"],["Instituto Dante Pazzanese de Cardiologia","Victor Hugo Martins da Silva","巴西","Sao Paulo","Sao Paulo"],["Centro Universitario Faculdade de Medicina do ABC (FMABC)","Elie Fiss","巴西","Sao Paulo","Santo Andre"],["Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP","Maria Eduarda Trocoli Zanetti","巴西","Sao Paulo","Ribeirao Preto"],["Clinica de Alergia Martti Antila","Martti Anton Antila","巴西","Sao Paulo","Sorocaba"],["Centro Clinico Nossa Saude / Centro Medico Sao Francisco","Clovis Arns da Cunha","巴西","Paraná","Curitiba"],["Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS","Daniela Cavalet Blanco","巴西","RS","Porto Alegre"],["Universidade Federal de Goias - Hospital das Clinicas da UFG","Amanda Da Rocha Oliveira Cardoso","巴西","Goiás","Goiania"],["Synergy Medical Clinic","Dina Fathy Awad","加拿大","Alberta","Sherwood Park"],["Inspiration Research","Kenneth Chapman","加拿大","Ontario","Toronto"],["Institut universitaire de cardiologie et de pneumologie de Quebec","Andreanne Cote","加拿大","Quebec","Quebec"],["St. Paul's Hospital","Delbert Dorscheid","加拿大","British Columbia","Vancouver"],["University of Calgary Foothills Campus","Richard Leigh","加拿大","Alberta","Calgary"],["University of British Columbia - Vancouver General Hospital","Celine Bergeron","加拿大","British Columbia","Vancouver"],["Centre d Investigation Clinique Mauricie - CIC Mauricie","Pierre-Alexandre Menard","加拿大","Quebec","Trois-Rivières"],["St. Joseph's Healthcare Hamilton - Charlton Campus","Parameswaran Nair","加拿大","Ontario","Hamilton"],["Dr. Syed Anees Medicine Professional Corporation","Syed Anees","加拿大","Ontario","Windsor"],["Plicni stredisko Teplice, s.r.o.","Stanislav Holub","捷克","N/A","Teplice"],["KASMED. s.r.o.","Milan Kasl","捷克","Jihocesky kraj","Tábor"],["HORNMED s r o","Tomas Rohovsky","捷克","Jihomoravsky kraj","Brno"],["MUDr Hofstetr Alergologicka a imunologicka ambulance","Tomas Hofstetr","捷克","N/A","Jihlava"],["Pneumologie Varnsdorf s.r.o.","Milan Sklenar","捷克","ústecky kraj","Varnsdorf"],["MUDr. I. Cierná Peterová s.r.o.","Ivana Cierna Peterova","捷克","N/A","Brandys nad Labem-Stará Boleslav"],["Oblastni nemocnice Kolin","Roztyslav Ozerov","捷克","N/A","Kolín"],["MediTrial s r o","Petr Kopecky","捷克","Jihocesky kraj","Jindrichuv Hradec"],["Alergologie Imunologie Centrum Podoli S R O","Anna Ticha","捷克","N/A","Kutna Hora"],["IKF Pneumologie Frankfurt","Andreas Eich","德国","N/A","Frankfurt"],["Praxis fur Pneumologie Xanthopoulos","Athanasios Xanthopoulos","德国","Brandenburg","Fürstenwalde/Spree"],["KPPK Studienzentrum","Olaf Schmidt","德国","Rhineland-Palatinate","Bendorf"],["POIS Sachsen GmbH","Juliana Brode","德国","Saxony","Leipzig"],["Asklepios MVZ Bayern GmbH","Florian Fliedner","德国","BY","Landsberg"],["Helix - Medical Excellence Center Mainz","Stephanie Korn","德国","Rhineland-Palatinate","Mainz"],["Research Center for Medical Studies","Anneliese Linnhoff","德国","Berlin","Berlin"],["Studienpraxis Berlin-Brandenburg Lennart Schaper","Lennart Schaper","德国","Berlin","Berlin"],["Universitaetsmedizin Rostock(Rostock University Medical Cente)","Johann Christian Virchow","德国","Mecklenburg-Vorpommern","Rostock"],["Thoraxklinik-Heidelberg gGmbH","Frederik Trinkmann","德国","Baden-Württemberg","Heidelberg"],["Santiago Clinic Hospital CHUS","Francisco Javier Gonzalez Barcala","西班牙","A Coruna","Santiago de Compostela"],["Hospital de la Santa Creu i Sant Pau","David Ramos Barbon","西班牙","Barcelona","Barcelona"],["FUTUREMEDS SEVILLA FATIMA","Eduardo Marquez Martin","西班牙","Andalucia","Sevilla"],["Hospital Universitario 12 de Octubre","Ismael Garcia-Moguel","西班牙","Madrid","Madrid"],["HOSP. UNIV. LUCUS AUGUSTI","Luis Alejandro Perez de Llano","西班牙","Lugo","Lugo"],["HOSP. VITHAS XANIT INTERNACIONAL","Gustavo Adolfo De Luiz Martinez","西班牙","N/A","Malaga"],["Pectus Respiratoy Health Barcelona","Juan Roldan Sanchez","西班牙","Barcelona","Barcelona"],["Pectus Respiratory Health Girona","Ana Moy","西班牙","Girona","Girona"],["HOSP. MEM. PUBLIO CORDON","Lorena Aida Comeche Casanova","西班牙","Pozuelo de Alarcon","Madrid"],["Hospital Universitari Son Espases","Francisco de Borja Garcia-Cosio Piqueras","西班牙","Islas Baleares","Palma"],["Hospital Universitari Germans Trias I Pujol (HUGTiP)","Carlos Martinez Rivera","西班牙","Barcelona","Barcelona"],["Hospital Universitario La Paz","David Romero-Ribate","西班牙","Madrid","Madrid"],["Hospital Universitario Marqués de Valdecilla","Juan Luis Garcia Rivero","西班牙","Cantabria","Santander"],["Bradford Royal Infirmary","Dinesh Saralaya","英国","England","West Yorkshire"],["Birmingham Heartlands Hospital","Adel Mansur","英国","N/A","Birmingham"],["Queen Anne Street Medical Centre","Brian Leaker","英国","England","London"],["St Peters Hospital","Monica Nordstrom","英国","England","Chertsey"],["Pinderfields Hospital","James McCreanor","英国","England","Stanley"],["Castle Hill Hospital","Shoaib Faruqi","英国","England","East Riding of Yorkshire"],["Ameli Biogroup LTD","Anthony Avornyo","英国","England","Waltham Abbey"],["university hospitals of leicester nhs trust - glenfield hospital","Dominick Shaw","英国","England","Leicestershire"],["Royal Liverpool University Hospital","Gareth Jones","英国","England","Liverpool"],["Queen Alexandra Hospital","Thomas Brown","英国","Hampshire","Portsmouth"],["Royal Papworth Hospital","Martin Knolle","英国","England","Cambridge"],["Erzsebet Gondozohaz","Janos Mucsi","匈牙利","N/A","Godollo"],["Omnimodus Elixír","Erika Unger","匈牙利","Gyor-Moson-Sopron","Mosonmagyaróvár"],["Semmelweis Egyetem (Semmelweis University)","Veronika Muller","匈牙利","Pest","Budapest"],["Obudai Egeszsegugyi Centrum","Zsofia Ajtay","匈牙利","Budapest","Budapest"],["Pulmoprotect Kft, Innomedic Egeszsegkozpont","Alpar Horvath","匈牙利","Budapest","Budapest"],["Derma B Kft","Zoltan Csontos","匈牙利","N/A","Debrecen"],["Koch Róbert Kórház és Rendelointézet","Melinda Szabo","匈牙利","Borsod-Abaúj-Zemplén","Edelény"],["Drug Research Center LLC","Erno Vitus","匈牙利","N/A","Balatonfured"],["UZSOKI UTCAI KORHAZ","Csaba Mathe","匈牙利","N/A","Budapest"],["KomplexLabor","Istvan Bozoky","匈牙利","N/A","Kecskemet"],["clinexpert obuda egeszsegcentruma","Renata Marietta Bocskei","匈牙利","Budapest","Budapest"],["Shaare Zedek Medical Center","Gabriel Izbicki","以色列","Jerusalem District","Jerusalem"],["Hadassah Medical Center","Neville Berkman","以色列","Jerusalem","Jerusalem"],["Barzilai Medical Center","Ori Wand","以色列","Southern","Ashkelon"],["Meir","David Shitrit","以色列","Central","Kfar Saba"],["Kaplan Medical Center","Evgeni Gershman","以色列","Central","Rehovot"],["Rabin Medical Center","Osnat Shtraichman","以色列","Tel Aviv","Petah Tikva"],["Tel Aviv Sourasky Medical Center","Amir Bar-Shai","以色列","Tel Aviv District","Tel Aviv Yafo"],["Yitzhak Shamir Medical Center","Benjamin Fox","以色列","Central","Be'er Ya'akov"],["Rambam Medical Center","Yaniv Dontan","以色列","N/A","Haifa"],["Bnai Zion Medical Center","Emilia Hardak","以色列","N/A","Haifa"],["Hindusthan Hospital","Srikanth Krishnamurthy","印度","Tamil Nadu","Coimbatore"],["Visakha Institute of Medical Sciences","Venkatesh Vulli","印度","AP","Visakhapatnam"],["Government TB and Chest Hospital","Sunil Kumar Raghumanda","印度","Andhra Pradesh","Visakhapatnam"],["Shree Hospital & Critical Care Center","Akash Balki","印度","Maharashtra","Nagpur"],["Sir Ganga Ram Hospital","Amit Dhamija","印度","Delhi","New Delhi"],["Gauhati Medical College and Hospital","Tribeni Sharma","印度","Assam","Guwahati"],["Nil Ratan Sircar Medical College and Hospital","Jaydip Deb","印度","West Bengal","Kolkata"],["All India Institute of Medical Sciences","Deependra Rai","印度","Bihar","Patna"],["Poona Hospital & Research Centre","Nitin Abhyankar","印度","Maharashtra","Pune"],["Epic Multispeciality hospital","Jay Mehta","印度","Gujarat","Ahmedabad"],["Medical College & Eden Hospital Kolkata","Sabyasachi Choudhury","印度","West Bengal","Kolkata"],["Yashoda Hospitals Best Hospital in Hitech City","Venkata Maturu","印度","TS","Kothaguda"],["Maharaja Agrasen Superspeciality Hospital","Manish Jain","印度","Rajasthan","Jaipur"],["Tokyo Shinagawa Hospital","Masaharu Shinkai","日本","N/A","Shinagawa-ku"],["Idaimae Minami Yojo Naika Clinic","Hiroshi Tanaka","日本","Hokkaidō Prefecture","Sapporo"],["Osaka Habikino Medical Center","Osamu Matsuno","日本","Osaka","Habikino"],["Yamaguchi University Hospital","Keiji Oishi","日本","Yamaguchi Prefecture","Ube"],["Tokyo-Eki Center-Building Clinic","Arihiro Kiyosue","日本","Tokyo","Tokyo"],["JA Kochi Hospital","Tsutomu Shinohara","日本","Kochi","Nankoku"],["Asan Medical Center","You Sook Cho","韩国","Seoul","Seoul"],["everance Hospital Yonsei University Health System","Jung-Won Park","韩国","Seoul","Seoul"],["Yeungnam University Hospital","Kwan-Ho Lee","韩国","Daegu Gwang'yeogsi","Daegu"],["Konkuk University Medical Center","Kwang Ha Yoo","韩国","Seoul","Seoul"],["Samsung Medical Center","Byung Jae Lee","韩国","Gangnam-gu","Seoul"],["Hanyang University Medical Center - Hanyang University Hospital","Sang-Heon Kim","韩国","Seoul","Seoul"],["Chonnam National University Hospital","Young-il Koh","韩国","Gwangju","Gwangju"],["Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)","Alicia Ramirez Rivera","墨西哥","Nuevo León","Monterrey"],["CICUM San Miguel","Jorge Eduardo Rosas-Cacho","墨西哥","Jalisco","Guadalajara"],["Medical Care & Research SA de CV","Pedro Alejandro Solis Martinez","墨西哥","Yucatan","Merida"],["INSTITUTO NACIONAL DE ENFERMEDADES RESPIRATORIAS","Maria Del Carmen Cano Salas","墨西哥","CDMX","Ciudad de México"],["Hospital SMIQ","Abraham Luna Ayala","墨西哥","Queretaro","Santiago de Queretaro"],["CIMEZAP","Rafael Fletes Zepeda","墨西哥","Jalisco","Zapopan"],["Centro Integral Medico SJR, SC","Mario Rosas Navarro","墨西哥","Querétaro","San Juan del Río"],["Instituto de Investigacion y Atencion Medica Especializada de Durango","Ricardo Alberto Ramirez Terrones","墨西哥","Dgo.","Durango"],["Hidra Investigacion","Elsa Marina Rey Ramirez","墨西哥","Ciudad de Mexico","Ciudad de Mexico"],["Hospital General Regional No 1 Carlos MacGregor Sanchez Navarro","Angel Velazquez","墨西哥","Ciudad de Mexico","Mexico City"],["Centrum Medycyny Oddechowej, Mroz Spolka Jawna","Robert Mróz","波兰","Podlaskie Voivodeship","Bialystok"],["Poradnia Alergologiczna E.J. Botulińska, A. Ploszczuk","Anna Ploszczuk","波兰","Województwo podlaskie","Bialystok"],["Dobrostan Gabinet Lekarskie","Ewa Pisarczyk-Bogacka","波兰","Lower Silesian Voivodeship","Wroclaw"],["Centrum Medyczne Lucyna Andrzej Dymek","Lucyna Dymek","波兰","Opole Voivodeship","Strzelce Opolskie"],["PULMAG Osrodek Badan Klinicznych i Diagnostyki Pulmonologicznej","Grzegorz Gasior","波兰","Silesian Voivodeship","Sosnowiec"],["Ankara Universitesi Tip Fakultesi Cebeci Hastanesi","Mungan Vesile Dilsad","土耳其","N/A","Ankara"],["Erciyes University Medical Faculty","Insu Yilmaz","土耳其","Kayseri","Kayseri"],["Istanbul Universitesi Cerrahpasa Tip Fakultesi","Bilun Gemicioglu","土耳其","N/A","Istanbul"],["Kirikkale University Medical Faculty(Kirikkale üniversitesi Tip Fakültesi)","Ayse Fusun Kalpaklioglu","土耳其","Kirikkale","Kirikkale"],["Mersin Universitesi Tip Fakultesi","Atis Nayci Sibel","土耳其","N/A","Mersin"],["Uludag University Medical Faculty","Dane Ediger","土耳其","N/A","Bursa"],["Süreyya Pasa Gogüs Cerrahisi Egitim ve Arastirma Hastanesi","Hakan Gunen","土耳其","Istanbul","Istanbul"],["Windom Allergy, Asthma and Sinus Specialists","Hugh Windom","美国","Florida","Sarasota"],["Midwest Clinical Research LLC","Robert Onder","美国","Missouri","St. Louis"],["velocity clinical research - vitalink research","Farhan Siddiqui","美国","South Carolina","Spartanburg"],["California Allergy & Asthma Medical Group Inc.","Ricardo Tan","美国","California","Los Angeles"],["Allergy, Asthma and Clinical Research","Martha Tarpay","美国","Oklahoma","Oklahoma City"],["National Jewish Health","Michael Wechsler","美国","CO","Denver"],["Vitalis Clinical Research Center","Syed Raza","美国","MI","Allen Park"],["Impact Medical: Allergy, Asthma, & Immunology","Jeffrey Weiss","美国","New Jersey","Paramus"],["Toledo Institute of Clinical Research, Inc.","Syed Rehman","美国","Ohio","Toledo"],["Equity Medical","Alissa McInerney","美国","New York","Bronx"],["Endeavor Health","Giselle Mosnaim","美国","Illinois","Lake Bluff"],["Bernstein Clinical Research Center","Jonathan Bernstein","美国","OH","Cincinnati"],["OK Clinical Research","Jeremy Cole","美国","Oklahoma","Edmond"],["Brigham & Women's Hospital","Elliot Israel","美国","Massachusetts","Boston"],["Boston Specialists","John Leung","美国","MA","Boston"],["Allianz Research Institute","Kareem Ahmad","美国","California","Westminster"],["Clinical Research Institute - Minneapolis","Gary Berman","美国","Minnesota","Minneapolis"],["Orion Clinical Research","William Howland","美国","Texas","Austin"],["University of Cape Town Lung Institute Pty Ltd (UCT Lung Institute)","Jonathan Peter","南非","Western Cape","Cape Town"],["Raslouw Private Hospital","Larisha Pillay-Ramaya","南非","GP","Pretoria"],["Netcare St Augustine's Hospital","Ismail Abdullah","南非","KwaZulu-Natal","Durban"],["Tiervlei Trial Centre","Haylene Nell","南非","Western Cape","Cape Town"],["Netcare Jakaranda Hospital - Emmed Clinical Research","Johannes Breedt","南非","Gauteng","Pretoria"],["Ubuntu Clinical Research Site","Gertruida Kruger","南非","GP","Krugersdorp"],["Enhancing Care Foundation (ECF)","Sundrapragasen Pillay","南非","KwaZulu-Natal","Durban"],["Durban Medical Centre","Farzana Hoosen","南非","KwaZulu-Natal","Durban"],["Langeberg Clinical Trials","Mohamed Mookadam","南非","Western Cape","Cape Town"],["newtown clinical research centre","Essack Mitha","南非","Gauteng","Johannesburg"],["Central Sooner Research","Elise Wiesner","美国","Oklahoma","Norman"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中日友好医院药物（器械）临床试验伦理委员会","同意","2026-07-17"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 30 ； 国际: 440 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；