上海PF-07275315注射液II期临床试验-一项在中度至重度哮喘患者中探索研究药物PF-07275315 的研究

登记号	CTR20252257	试验状态	进行中
申请人联系人	于涛	首次公示信息日期	2025-06-11
申请人名称	Pfizer Inc./ 辉瑞投资有限公司/ Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

登记号	CTR20252257
相关登记号	暂无
药物名称	PF-07275315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	中度至重度哮喘
试验专业题目	一项在控制不佳的中度至重度哮喘成人研究参与者中评估PF-07275315的疗效和安全性的II期、随机、双盲、安慰剂对照、平行组、剂量范围探索研究
试验通俗题目	一项在中度至重度哮喘患者中探索研究药物PF-07275315 的研究
试验方案编号	C4531029	方案最新版本号	最终方案
版本日期:	2024-11-21	方案是否为联合用药	否

申请人名称	[["Pfizer Inc."],["辉瑞投资有限公司"],["Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC"]]
联系人姓名	于涛	联系人座机	021-28935395	联系人手机号	13818437012
联系人Email	tao.yu@pfizer.com	联系人邮政地址	上海市-上海市-静安区南京西路1168号36楼	联系人邮编	200041

在控制不佳的中度至重度哮喘研究参与者中评估PF-07275315 的疗效和安全性，并提供量效关系的初步评估。本研究还将评估与PF-07275315 相关的药代动力学特征、免疫原性和生物标志物。

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 70岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["筛选时为18 至70 岁（或根据当地法规确定的最低知情同意年龄）。"],["根据公认的国际和/或当地指导原则（例如2024 年GINA 报告），筛选前有至少12 个月的持续性中度至重度哮喘病史。n注：在源文件中应有按照GINA 第4/5 级（即中至高剂量ICS 联合长效支气管舒张剂的治疗方案）开具了12 个月的维持（控制）治疗的医疗记录。n支气管舒张试验阳性或乙酰胆碱激发试验阳性的历史证据。"],["在筛选访视前12 个月内必须发生过至少1 次需要接受至少3 天的系统性糖皮质激素（口服或胃肠道外给药）治疗的哮喘恶化。n注：在源文件中应存有转诊医生或主治医生记录或出院总结的遮盖后版本和/或药房记录/处方，以确认哮喘加重（即哮喘症状恶化并需要接受至少3 天的系统性糖皮质激素治疗）。"],["筛选期间，使用支气管舒张剂前FEV1 为预测正常值的≥ 30% 至< 80%。n注：在筛选访视后，只有在研究参与者已暂停使用第6.9.1 节中所述的维持和缓解治疗时，才应进行肺活量测定检查。如果在初次访视时FEV1 不符合此标准，可在筛选访视之后重复进行筛选访视肺活量测定检查，以确认资格。n注：在第-2 周和第0 周之间（第1 天给药前）收集3 次使用支气管舒张剂前FEV1 测定值中的至少有2 次达到上述范围（与其平均值的差必须在±15% 范围内）。"],["筛选期间的肺活量测定中至少有一次支气管舒张剂反应阳性，表现为吸入400μg 沙丁胺醇（或等效的SABA）后15 - 30 分钟（或根据当地治疗实践标准）FEV1 至少增加12% 和200 mL。"],["筛选访视前的12 个月一直按照GINA 第4/5 级（途径1 或途径2）接受维持（控制）治疗，其中至少包括中剂量至高剂量ICS-LABA 复方药物，且筛选访视前的至少3 个月一直保持剂量稳定。n注：需要使用额外控制疗法来治疗哮喘的研究参与者若在筛选前已接受稳定的剂量至少3 个月，并且在研究期间没有改变剂量，且该疗法并非禁用的既往/合并药物，视为有资格参加本研究。n研究参与者需要愿意在研究期间继续接受其维持（控制）治疗。"],["筛选时体重指数为18 - 40 kg/m2。"],["筛选访视时和随机化前（第-2 周、第-1 周或第1 天[给药前] 访视中的至少一次）的ACQ-5 评分≥ 1.5。"]]
排除标准	[["可能增加研究参与的风险或（根据研究者判断）可能使研究参与者不适合参加研究的任何医学或精神状况，包括近期（过去一年内）或主动自杀想法/行为或实验室检查异常。n注：合并症过敏性/特应性疾病（例如AD、慢性鼻窦炎伴鼻息肉[CRSwNP]、过敏性鼻炎[AR]）并非排除标准，前提是这些合并症不干扰哮喘评估且不需要使用禁用药物n注：排除需要系统性免疫抑制治疗的自身免疫性疾病（例如炎症性肠病、类风湿性关节炎、系统性红斑狼疮）。"],["根据当地标准治疗，筛选访视前12 个月内存在除哮喘以外的肺部疾病的证据，即临床证据、肺活量测定或影像学检查（胸部X 线检查、CT、MRI），包括但不限于：n慢性阻塞性肺疾病n其他肺气肿性肺疾病，例如α-1 抗胰蛋白酶疾病n囊性纤维化n肺气肿n特发性肺纤维化nChurg-Strauss 综合征n过敏性支气管肺曲霉病n肉状瘤病"],["诊断为任何以下急性或慢性感染或有以下感染史：n筛选前2 周内存在需要治疗的活动性蠕虫或寄生虫感染；n注：还排除了疑似寄生虫感染或寄生虫感染高风险，除非随机化前的临床或实验室评估已排除活动性感染；n第1 天前60 天内存在需要住院或全身（胃肠道外）抗菌治疗的感染；n第1 天前6 个月内存在任何被研究者判定为机会性感染或具有临床意义的感染。"],["既往或当前使用任何禁用伴随用药，或不愿意或不能使用要求的伴随用药。"],["既往或合并使用获批或试验性生物疗法（例如IL-4Rα、TSLP、IL-5 或IgE 的抑制剂）或者靶向合成药物（例如JAK 抑制剂），用于治疗哮喘或其他2 型炎症性疾病，包括但不限于：AD、EoE、CRS（详细信息见第6.9 节）。n注：如果研究参与者可能已在临床试验中或其他情况下（例如[2024 年GINA 指导原则] 第5 级治疗）接受过这些生物制剂且不被视为治疗失败，或者已接受治疗但由于缺乏治疗机会或与安全性或缺乏疗效无关的其他原因而终止治疗，则只要在筛选前停药至少5 个半衰期，就符合入组研究的资格。需要逐例获得申办者批准。n注：生物疗法治疗失败或发生不良反应的研究参与者没有资格入组研究。n注：可接受既往针对除哮喘以外的任何其他适应症接受过抗IgE（例如奥马珠单抗）治疗，但在筛选前至少1 年停止此类治疗的研究参与者。"],["筛选访视前28 天直到研究结束之间接受任何剂量水平的系统性（口服或注射）糖皮质激素治疗（除非用于治疗急性加重）。"],["既往接受（筛选前12 周内）或计划合并接受免疫球蛋白补充治疗（例如静脉注射用免疫球蛋白[IV Ig] 或皮下注射用免疫球蛋白[SC Ig]）。"],["对治疗性抗体、PF-07275315 或制剂辅料有过敏反应史。"],["过去24 个月内接受过支气管热整形术。"],["筛选访视前30 天或5 个半衰期内（以较长者为准）接受过研究用药品给药。在参与本研究期间的任何时间参与其他研究用药品（药物或疫苗）的研究。n注：当地法规或其他因素可能要求30 天以上的洗脱期。"],["肾功能损伤定义为eGFR < 60 mL/min/1.73 m2。"],["肝功能障碍，定义为：n总胆红素≥ 1.5 × ULN（存在Gilbert 综合征时，直接胆红素> ULN 为排除标准）nAST ≥ 2.5 × ULNnALT ≥ 2.5 × ULN"],["血液学异常，定义为：nANC ≤ 1500 个细胞/mm3n血小板≤ 100,000/mm3n血红蛋白≤ 12.0 g/dL（女性）和≤ 13.0 g/dL（男性）"],["活动性或潜伏性HIV、乙型肝炎和/或丙型肝炎。"],["存在活动性或潜伏性TB，或未经充分治疗的结核分枝杆菌(TB) 感染的证据。n如果研究参与者正在接受活动性或潜伏性TB 感染治疗，则必须将其从本研究n中排除。"],["基线标准12 导联心电图证实存在可能影响研究参与者安全或研究结果解读的临床相关异常（例如，QTcF > 450 ms、完全LBBB、急性或发病时间不明的心肌梗塞体征、提示心肌缺血的ST 段和/或T 波变化、二度或三度房室传导阻滞或严重的缓慢型心律失常或快速性心律失常）。如果QTcF 超过450 ms或QRS 超过120 ms，则应再重复2 次ECG，并使用3 个QTcF 或QRS 值的平均值确定研究参与者的资格。在排除研究参与者之前，应由具有ECG 判读经验的研究者重新判读具有异常结果的计算机解读的ECG。"],["筛选期（访视1 至访视4/第0 周）内的维持治疗依从性低于80%。"],["已知或疑似酒精滥用或药物滥用。"],["吸烟史≥ 10 包年。"],["筛选访视前12 个月内仍在吸烟或吸电子烟。"],["筛选前12 周内（男性）或16 周内（女性）献血（不包括献血浆）约≥ 400 mL。"],["直接参与研究实施的研究中心工作人员及其家人、以其他方式受研究者监管的研究中心工作人员，以及直接参与本研究实施的申办者和申办者代表员工及其家人。"]]

试验药

[["中文通用名:PF-07275315注射液 英文通用名:NA 商品名称:NA","剂型:注射液 规格:100mg/mL 用法用量:治疗组A：第1天800mg，第4周和第8周400mg，Q4W给药治疗组B：第1天200mg，第4周和第8周100mg，Q4W给药治疗组C：第1天50mg，第4周和第8周25mg，Q4W给药 用药时程:12周"]] 序号 名称 用法

对照药

[["中文通用名:安慰剂 英文通用名:NA 商品名称:NA","剂型:注射液 规格:1ml/瓶 用法用量:治疗组D：安慰剂Q4W，第1天、第4周和第8周给药。皮下给药；主要成分：L-组氨酸、L-组氨酸盐酸盐一水合物、聚山梨酯80、蔗糖、乙二胺四乙酸二钠二水合物（EDTA）、L-精氨酸盐酸盐、注射用水。 用药时程:12周"],["中文通用名:安慰剂 英文通用名:NA 商品名称:NA","剂型:注射液 规格:1ml/瓶 用法用量:治疗组D：安慰剂Q4W，第1天、第4周和第8周给药。皮下给药；主要成分：L-组氨酸、L-组氨酸盐酸盐一水合物、聚山梨酯80、蔗糖、乙二胺四乙酸二钠二水合物（EDTA）、L-精氨酸盐酸盐、注射用水。 用药时程:12周"],["中文通用名:安慰剂 英文通用名:NA 商品名称:NA","剂型:注射液 规格:1ml/瓶 用法用量:治疗组D：安慰剂Q4W，第1天、第4周和第8周给药。皮下给药；主要成分：L-组氨酸、L-组氨酸盐酸盐一水合物、聚山梨酯80、蔗糖、乙二胺四乙酸二钠二水合物（EDTA）、L-精氨酸盐酸盐、注射用水。 用药时程:12周"]] 序号 名称 用法

主要终点指标及评价时间	[["在嗜酸性粒细胞计数≥300个细胞/μL的中度至重度哮喘研究参与者中评估PF-07275315 与安慰剂相比的疗效.第12 周时使用支气管舒张剂前第一秒用力呼气量(FEV1)较基线变化(CFB)。","第12周","有效性指标"],["在中度至重度哮喘研究参与者中评估PF-07275315 的安全性。n1. 经治疗出现的不良事件（TEAE，全因和治疗相关）的发生率。n2. 经治疗出现的严重不良事件(SAE) 的发生率。","整个研究","安全性指标"],["3. TEAE 或SAE 导致的停药。n4. 有临床意义的治疗相关异常实验室值、生命体征或心电图。","整个研究","安全性指标"]] 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	[["第12 周时使用支气管舒张剂前FEV1 % 预测值CFB。","第12周","有效性指标"],["第12 周时使用支气管舒张剂前FEV1 的CFB。","第12周","有效性指标"],["第12 周时哮喘控制问卷（5 个问题版[ACQ-5]）总评分CFB。n第12 周时哮喘生活质量问卷(标准化活动) (AQLQ) 自我评定总评分CFB。","第12周","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	张旻	学位	医学博士	职称	主任医师
	电话	13482345145	Email	13482345145@163.com	邮政地址	上海市-上海市-虹口区海宁路100号
	邮编	200080	单位名称	上海市第一人民医院

[["上海市第一人民医院","张旻","中国","上海市","上海市"],["西安医学院第一附属医院","王胜昱","中国","陕西省","西安市"],["广州医科大学附属第三医院","魏立平","中国","广东省","广州市"],["江西省人民医院（南昌医学院第一附属医院）","肖祖克","中国","江西省","南昌市"],["内蒙古医科大学附属医院","高俊珍","中国","内蒙古自治区","呼和浩特市"],["四川大学华西医院","文富强","中国","四川省","成都市"],["吉林大学第二医院","张捷","中国","吉林省","长春市"],["南京市第一医院","方苏榕","中国","江苏省","南京市"],["内蒙古自治区人民医院","徐毛冶","中国","内蒙古自治区","呼和浩特市"],["上海市肺科医院","程克斌","中国","上海市","上海市"],["徐州医科大学附属医院","陈碧","中国","江苏省","徐州市"],["首都医科大学附属北京朝阳医院","黄克武","中国","北京市","北京市"],["上海交通大学医学院附属瑞金医院","汤葳","中国","上海市","上海市"],["杭州市第一人民医院（西湖大学附属杭州市第一人民医院）","王利民","中国","浙江省","杭州市"],["南京医科大学第一附属医院（江苏省人民医院）","姚欣","中国","江苏省","南京市"],["中日友好医院","苏楠","中国","北京市","北京市"],["OK Clinical Research","Jeremy Cole","美国","OKLAHOMA","Edmond"],["Asthma & Allergy Center","Dr.Syed M Rehman Inc","美国","OHIO","Toledo"],["Alllergy & Asthma Associates of Southern California dba Southern California Research","Dr.Warner W. Carr","美国","CALIFORNIA","Mission Viejo"],["Washington University School of Medicine","Dr.James Krings","美国","MISSOURI","St. Louis"],["The University of Kansas Medical Center","Dr.Mario Castro","美国","KANSAS","Kansas City"],["Alina Clinical Trials, LLC.","Dr.Barbara Stark Baxter","美国","TEXAS","Dallas"],["A. Alfred Taubman Health Care Center","Njira L Lugogo","美国","MICHIGAN","Ann Arbor"],["Clinical Research Associates of Central PA","Dr.Sandeep Bansal","美国","PENNSYLVANIA","DuBois"],["American Health Research","Dr.Selwyn Spangenthal","美国","NORTH CAROLINA","Charlotte"],["Metroplex Pulmonary and Sleep Center Drive","Dr.Shahrukh A. Kureishy","美国","TEXAS","McKinney"],["California Allergy and Asthma Medical Group","Dr.Ricardo Antonio Tan","美国","CALIFORNIA","Los Angeles"],["Kowa Clinic","Dr.Tsuyoshi Yamato","日本","TOKYO","Tokyo"],["Okayama Rosai Hospital","Dr.Nobukazu Fujimoto","日本","OKAYAMA","Okayama"],["Fukuwa Clinic","Dr.Yasushi Fukushima","日本","TOKYO","Chuo-ku"],["National Hospital Organization Yokohama Medical Center","Dr.Naomi Tsurikisawa","日本","KANAGAWA","Yokohama"],["NHO Kinki Chuo Chest Medical Center","Dr.Toru Arai","日本","OSAKA","Sakai"],["National Hospital Organization Osaka Minami Medical Center","Dr.miyuki okuda","日本","OSAKA","Kawachinagano"],["Greater Heights & Memorial Pulmonary and Sleep","Jose Melendez","美国","TEXAS","Houston"],["National Hospital Organization Minami Kyoto Hospital","Masayoshi Minakuchi","日本","KYOTO","joyo"],["Tokyo-Eki Center-building Clinic","Dr.Arihiro Kiyosue","日本","TOKYO","Chuo-ku"],["Fujisawa City Hospital","Motoyasu Iikura","日本","KANAGAWA","Fujisawa"],["Hammersmith Hospital","Salman Siddiqui","英国","NA","London"],["South Texas Medical Research Institute, Inc., DBA TTS Research","Dr.David Fuentes","美国","TEXAS","Boerne"],["Kobe City Medical Center West Hospital","Dr.Masahiro Kaneko","日本","HYOGO","Kobe"],["Tohno Chuo Clinic","Dr.Hiroyuki Ohbayashi","日本","GIFU","Mizunami"],["Maopolskie Centrum Alergologii","Dr.Malgorzata Teresa Bederska","波兰","MALOPOLSKIE","Krakow"],["Tokyo Medical University Hachioji Medical Center","Prof.Kenji Tsushima","日本","TOKYO","Hachioji"],["The University of Arizona","Tara F Carr","美国","ARIZONA","Tucson"],["Ehime Prefectural Central Hospital","Tomoya Katsuta","日本","EHIME","Matsuyama"],["Bradford Royal Infirmary","Dr.Dinesh Saralaya","英国","UNITED KINGDOM","Bradford"],["KLIMED Marek Klimkiewicz","Justyna Kolodynska-Jeridi","波兰","LUBELSKIE","Bychawa"],["Clinical Research of Rock Hill","Dr.Michael Denenberg","美国","SOUTH CAROLINA","Rock Hill"],["Yale University School of Medicine","Dr.Geoffrey Geoffrey Chupp","美国","CONNECTICUT","New Haven"],["Medical Center Pulmovision OOD","Miroslav Mihaylov","保加利亚","NA","Sofia"],["Medical Center Pulmovision OOD","Dr.Shih-Lung Cheng","中国台湾","NEW TAIPEI","Taipei"],["Clinical Research Institute","Dr.Gary D. Berman","美国","MINNESOTA","Minneapolis"],["AZ Sint-Maarten, Campus Leopoldstraat 2","Mr.Muriel Lins","比利时","ANTWERPEN","Mechelen"],["ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.","Dr.Bernadetta Majorek-Olechowska","波兰","MALOPOLSKIE","Tarnow"],["Medical Center Pulmo - 2018 EOOD","Veselin Todorov Kalfov","保加利亚","HASKOVO","Haskovo"],["Allergy and Asthma Associates of Santa Clara Valley Research Center","Dr.James D. Wolfe","美国","CALIFORNIA","San Jose"],["Medical Center","Prof.Dimo Mitev Dimov","保加利亚","STARA ZAGORA","Stara Zagora"],["PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna","Dr.Grzegorz Jerzy Gasior Mr","波兰","SLASKIE","Sosnowiec"],["Diamond Clinic","Dr.Barbara Rewerska","波兰","MALOPOLSKIE","Krakow"],["Taichung Veterans General Hospital","Prof.Pin-Kuei Fu","中国台湾","TAICHUNG","Taichung"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Prof.Chau-Chyun Sheu","中国台湾","KAOHSIUNG","Kaohsiung"],["CENTRUM MEDYCZNE ,,ALL - MED`` BADANIA KLINICZNE","Dr.Grazyna Pulka","波兰","MALOPOLSKIE","Krakow"],["Velocity Clinical Research, Mobile","Dr.Lawrence James Sindel","韩国","ALABAMA","Mobile"],["Severance Hospital, Yonsei University Health System","Dr.Jung-Won Park","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Jeonbuk National University Hospital","Prof.YongChul Lee","韩国","JEONRABUGDO","Jeonju-si"],["The Catholic University of Korea, Eunpyeong St. Mary’s Hospital","Prof.Sang Haak Lee","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Konkuk University Medical Center","Kwang Ha Yoo","韩国","PUSAN-KWANGYOKSHI","Seoul"],["Robert Wood Johnson University Hospital New Brunswick","Dr.reynold panettieri jr","美国","NEW JERSEY","New Brunswick"],["The Catholic Univ. of Korea Seoul St. Mary`s Hospital","Chin Kook Rhee","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Asan Medical Center","Dr.You Sook Cho","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Yeungnam Univeristy Medical Center","Dr.Kwan H0 Lee","韩国","TAEGU-KWANGYOKSHI","Daegu"],["University of Wisconsin Hospitals and Clinics","Dr.Mark Hubert Moss","美国","WI","Madison"],["Impact Medical / Circuit Clinical","Dr.Jeffrey Weiss","美国","NEW JERSEY","Riverdale"],["Hospital Marques de Valdecilla","Dr.Juan Luis Garcia Rivero","西班牙","NA","Santander"],["UZ Gent","Prof.Guy Brusselle","比利时","OOST-VLAANDEREN","Gent"],["Centre Hospitalier Regional de la Citadelle","Dr.Maud Deschampheleire","比利时","NA","Liege"],["Hospital Universitario Virgen de la Victoria","Dr.Jose luis Velasco garrido","西班牙","MALAGA","Malaga"],["Dobrostan Gabinet Lekarskie","Dr.Ewa Pisarczyk-Bogacka","波兰","DOLNOSLASKIE","Wroclaw"],["Hospital Universitario La Paz","David Romero-Ribate","西班牙","NA","Madrid"],["Hospital Universitario 12 De Octubre","Ismael Garcia-Moguel","西班牙","NA","Madrid"],["NZOZ Alergo-Med Poradnia Alergologiczna i Pulmonologiczna","Danuta Madra-Rogacka","波兰","NA","Poznan"],["DCC Aleksandrovska EOOD","Maria Staevska","保加利亚","NA","Sofia"],["Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento","Marco Caminati","意大利","OTHER","Verona"],["Azienda Ospedaliera Universitaria Senese","PAOLO CAMELI","意大利","TOSCANA","Siena"],["Istituto Clinico Humanitas","Prof.Enrico Marco Heffler","意大利","NA","Rozzano"],["National Taiwan University Hospital","Dr.Ping Hung Kuo","中国台湾","TAIPEI","Taipei"],["Allergy, Asthma and Clinical Research","Dr.Martha Maria Tarpay","美国","OKLAHOMA","Oklahoma City"],["Premier Research Center, LLC","Dr.Clyde Southwell MD, FCCP","美国","TENNESSEE","Hendersonville"],["Centrum Medycyny Oddechowej Spolka Jawna","Prof.Robert Marek Mroz MD","波兰","PODLASKIE","Biaystok"],["Allergy & Asthma Clinical Research","Dr.Joshua Samuel Jacobs","美国","CALIFORNIA","Walnut Creek"],["Addenbrooke`s Hospital","Dr.Martin Daniel Knolle","英国","ENGLAND","Cambridge"],["North Manchester General Hospital","Nav Sehgal","英国","NA","Crumpsall"],["Wythenshawe Hospital","Stephen Fowler","英国","NA","Manchester"],["Mazda Hospital","Yojiro Onari","日本","HIROSHIMA","Aki-gun Fuchu-cho"],["Kirigaokatsuda Hospital","Dr.Tetsuya Kawano","日本","FUKUOKA","Kitakyusyu"],["Oita Red Cross Hospital","Dr.Masahiro Hata","日本","OITA","Oita"],["Fujieda Municipal General Hospital","Naoki Koshimizu","日本","SHIZUOKA","Fujieda-shi"],["Fukuoka National Hospital","Takehito Fukushima","日本","FUKUOKA","Fukuoka"],["National Hospital Organization Minamiwakayama Medical Center","DrMakoto Hagiwara","日本","WAKAYAMA","Tanabe"],["Niigata University Medical & Dental Hospital","DrToshiyuki Koya","日本","NIIGATA","Niigata-shi"],["Okayama City General Medical Center Okayama City Hospital","DrNoboru Hamada","日本","OKAYAMA","Okayama"],["AO Azienda Ospedaliera Ordine Mauriziano Di Torino","Luisa Brussino","意大利","TURIN","Torino"],["National Hospital Organization Fukuokahigashi Medical Center","Dr.Shohei Takata","日本","FUKUOKA","Koga"],["SNZOZ Alergologia Plus Poznan","Ewa Springer","波兰","NA","Poznan"],["HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID","Jose Maria Echave-Sustaeta Maria-Tome","西班牙","MADRID","Pozuelo de Alarcon"],["Azienda Sanitaria Ospedaliera S Luigi Gonzaga","Prof.Fabio Luigi Massimo Ricciardolo","意大利","TORINO","Orbassano"],["Azienda Ospedaliera Universitaria Cagliari","Stefano Del Giacco","意大利","CAGLIARI","Monserrato"],["Castle Hill Hospital","Shoaib Faruqi","英国","NA","Cottingham"],["Instituto Ave Pulmo","Luis Wehbe","阿根廷","BUENOS AIRES","MAR DEL PLATA"],["Synapta Clinical Research Centre","Dr.Farzana Hoosen","南非","KWAZULU-NATAL","DURBAN"],["Aliwal Shoal Medical Centre","Trevenesan Padayachee","南非","KWAZULU-NATAL","Umkomaas"],["Instituto de Enfermedades Respiratorias e Investigacion Medica","Andrea Cintia Medina","阿根廷","BUENOS AIRES","Villa Vatteone"],["Fundacion Respirar","Dr.Maria Cristina De Salvo","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Buenos Aires"],["Tiervlei Trial Centre","Dr.Ramatsiele Petrus Masekoameng","南非","WESTERN CAPE","Cape Town"],["Newtown Clinical Research","Dr.Essack Aziz Mitha","南非","GAUTENG","Johannesburg"],["Emmed Research","Dr.Johannes Breedt","南非","GAUTENG","Pretoria"],["North Cypress Medical Center","Dileep Puppala","美国","TEXAS","Cypress"],["Hiroshima Prefectural Hospital","Nobuhisa Ishikawa","日本","HIROSHIMA","Hiroshimashi"],["Centro Medico de Enfermedades Respiratorias","Dr.Miguel Angel Bergna MD","阿根廷","BUENOS AIRES","Florida, Vicente Lopez"],["Centro de Investigaciones Metabolicas (CINME)","Dr.Gonzalo Saenz","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Capital Federal"],["FUNDACION CIDEA","Dr.Jorge Fernando Maspero","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Ciudad de Buenos Aires"],["Instituto de Salud Respiratoria","Dr.Pedro Carlos Elias","阿根廷","MENDOZA","City"],["Instituto Especialidades de la Salud Rosario","Dr.Darío Daniel Ardusso","阿根廷","SANTA FE","Rosario"],["Netcare St Augustine`s Hospital","Dr.Ismail Aboobaker Abdullah","南非","KWAZULU-NATAL","Durban"],["IDIM – Instituto de Investigaciones Metabolicas","Dr.Ricardo Alfonso del Olmo","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Ciudad Autonoma de Buenos Aires"],["Instituto Jalisciense de Investiacion Clinica","Dr.dante daniel hernandez colin DR","墨西哥","JALISCO","guadalajara"],["Centro Respiratorio Quilmes","Dr.Marcelo Jose Fernandez","阿根廷","BUENOS AIRES","Quilmes"],["University of Cape Town Lung Institute (Pty) Ltd","Prof.Richard Nellis van Zyl-Smit","南非","WESTERN CAPE","Cape Town"],["MEDITRIAL s.r.o.","Dr.Petr Kopecky","捷克共和国","JIHOCESKY KRAJ","Jindichuv Hradec"],["Centro de Investigacion y Atencion Integral Durango","Dr.Ricardo Alberto Ramirez","墨西哥","DURANGO","Durango"],["Clinstile, S.A. de C.V.","Dr.Jose Ivan Juarez Ramirez","墨西哥","DISTRITO FEDERAL","Mexico"],["Unidad de Investigacion Clinica en Medicina","Dr.ALICIA Ramirez","墨西哥","NUEVO LEON","MONTERREY, NUEVO LEON"],["Szalay Janos Rendelointezet","Edina Kurucz","匈牙利","HAJDU-BIHAR","Hajdunanas"],["IBAMEDICA","Dr.Martin Maillo","阿根廷","SANTA FE","Santa Fe"],["Centro Integral Medico SJR S.C","Mario Alberto Rosas Navarro","墨西哥","QUERETARO","San Juan del Rio"],["Centro de Medicina Respiratoria","Dr.CARLOS FABIAN VICTORIO M.D.","乌拉圭","NA","Concepcion del Uruguay"],["Hospital Angeles Vistahermosa","Ruth Cerino Javier","墨西哥","NA","Villahermosa"],["CEFISPIRO s.r.o.","Dr.Petra Filipova","捷克共和国","NA","Lovosice"],["Centro Platense en Investigaciones Respiratorias","Dr.Gabriel Garcia","阿根廷","BUENOS AIRES","La Plata"],["CARE - Centro de Alergia y Enfermedades Respiratorias","Dr.Hernan Daniel Piza","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Villa Crespo"],["Investigaciones en Patologias Respiratorias","Ms.Ana Maria Stok","阿根廷","TUCUMAN","San Miguel de Tucuman"],["Arke SMO S.A de C.V","Amado Ramirez Hernandez","墨西哥","VERACRUZ","Veracruz"],["Infer-Med KFT Davinci Klinika","Dr.Marta Papp","匈牙利","BARANYA","Pecs"],["Pinderfields General Hospital","James McCreanor","英国","NA","Wakefield"],["Jongaie Research","Dr.Douwe Marcus De Jong","南非","GAUTENG","Pretoria"],["Unidad Medica para la Salud Integral Interior A","Dr.Rodolfo Posadas-Valay","墨西哥","NUEVO LEON","San Nicolas de Los Garza"],["Global Clinical Trials","Dr.Larisha Pillay-Ramaya","南非","GAUTENG","Pretoria"],["Worthwhile Clinical Trials","Dr.NAZREEN JEEWA HUSSEN","南非","GAUTENG","Benoni"],["Hospital Internacional Xanit","Dr.Gustavo De luiz Martinez","西班牙","ANDALUCIA","Benalmadena"],["Mudr.I.Cierna Peterova s.r.o.","Dr.Ivana Cierna Peterova","捷克共和国","STREDOCESKY KRAJ","Brandys nad Labem"],["FUNDACION SCHERBOVSKY","Dr.Pablo Saez Scherbovsky","阿根廷","MENDOZA","Mendoza"],["Erzsebet Gondozohaz","Dr.Janos Mucsi","匈牙利","PEST","Godollo"],["Koch Robert Korhaz es Rendelointezet","Melinda Szabo","匈牙利","BORSOD-ABAUJ-ZEMPLEN","Edeleny"],["Centro Privado de Medicina Respiratoria","Luis Dario Larrateguy","阿根廷","ENTRE RIOS","Parana"],["Faculty Hospital Hradec Kralove","Mrs.Irena Krcmova","捷克共和国","NA","Hradec Kralove"],["CIMER Centro Integral de Medicina Respiratoria","Dr.Hector Hugo Altieri","阿根廷","TUCUMAN","San Miguel de Tucuman"],["Instituto de Alergia y Enfermedades Respiratorias (InAER)","Dr.Anahi Yanez","阿根廷","BUENOS AIRES","CABA"],["Fundacion para la Asistencia e Investigacion Clinica en Enfermedades Prevalentes (FAICEP)","Horacio Budani","阿根廷","NA","Buenos Aires"],["Omnimodus Elixir Kft.","Dr.Erika Unger","匈牙利","GYOR-MOSON-SOPRON","Mosonmagyarovar"],["Chang Gung Medical Foundation-Linkou Branch","Horng-Chyuan Lin","中国台湾","TAOYUAN","Taoyuan City"],["Hamamatsu Rosai Hospital","Mikio Toyoshima","日本","SHIZUOKA","Hamamatsu"],["Newport Native MD","Dr.Ryan M. Klein","美国","CALIFORNIA","Newport Beach"],["Layrek Clinical Research","Hassan Abouhouli","美国","OKLAHOMA","Tulsa"],["Ubuntu Clinical Research - Krugersdorp","Dr.Gertruida Magdalena Kruger","南非","GAUTENG","Krugersdorp"],["Synexus - Helderberg Clinical Research Centre - Somerset West","Dr.Susanna Magrieta Roux","南非","WESTERN CAPE","Somerset West"],["Ubuntu Clinical Research - Lenasia","Dr.Natasha Joseph","南非","GAUTENG","Lenasia"],["Changhua Christian Hospital","Dr.Ching-Hsiung Lin","中国台湾","CHANGHUA","Changhua County"],["Arcispedale Santa Maria Nuova IRCCS","Nicola Cosimo facciolongo","意大利","NA","Reggio Emilia"],["Wake Forest Baptist Health","Dr.Wendy C. Moore","美国","NC","Winston-Salem"],["University of Mississippi Medical Center","Dr.Gailen Dougherty Marshall Jr.","美国","MS","Jackson"],["PRO422 Clinical Research Wilgers","Dr.Larry Duncan Mey","南非","GAUTENG","Pretoria"],["Colorado ENT & Allergy - St. Peregrine","Eric Louis Caplan","美国","COLORADO","Colorado Springs"],["Innovo Research - Christie Clinic","Dr.Kaushik Patel M.D.","美国","ILLINOIS","Champaign"],["IATROS INTERNATIONAL","Dr.Nyda Fourie","南非","FREE STATE","Bloemfontein"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市第一人民医院医学伦理委员会","同意","2024-12-25"]]

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: 29 ； 国际: 252 ；
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：2025-05-20；
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；