上海噻托溴铵+Olodaterol吸入用固定剂量复方制剂溶液(高剂量组）III期临床试验-噻托溴铵+Olodaterol复方制剂与单药在治疗COPD时的比较

登记号	CTR20131479	试验状态	已完成
申请人联系人	勃林格殷格翰临床试验信息公示组	首次公示信息日期	2014-08-25
申请人名称	Boehringer Ingelheim International GmbH/ Boehringer Ingelheim Pharma GmbH & Co. KG/ 勃林格殷格翰国际贸易（上海）有限公司

登记号	CTR20131479
相关登记号	CTR20131478
药物名称	噻托溴铵+Olodaterol 吸入用固定剂量复方制剂溶液 (高剂量组）
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	慢性阻塞肺病
试验专业题目	在COPD患者中进行的研究，评价经口吸入噻托溴铵+Olodaterol每日1次，治疗52周的疗效和安全性，并与单药治疗相比较
试验通俗题目	噻托溴铵+Olodaterol复方制剂与单药在治疗COPD时的比较
试验方案编号	1237.6	方案最新版本号	暂无
版本日期:	暂无	方案是否为联合用药	企业选择不公示

申请人名称	1 2 3
联系人姓名	勃林格殷格翰临床试验信息公示组	联系人座机	+86-21-52883966	联系人手机号	暂无
联系人Email	MEDCTIDgroup.CN@boehringer-ingelheim.com	联系人邮政地址	中国上海市南京西路1601号越洋广场29楼	联系人邮编	200040

总体目的为评价慢性阻塞性肺疾病患者通过Respimat吸入器每日1次吸入噻托溴铵+Olodaterol 吸入用固定剂量复方制剂溶液的长期疗效和安全性

试验分类	安全性和有效性	试验分期	III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	40岁(最小年龄)至 无限制岁(最大年龄)
性别	男+女
健康受试者	有
入选标准	1 COPD患者 2 患者的气道阻塞必须相对稳定，使用支气管扩张剂后FEV1 3 年龄40 岁或以上的男性、女性患者 4 患者目前吸烟，或者有吸烟史（超过10 包年）
排除标准	1 受试者除了患有COPD 外还患有其它重大疾病 2 有临床意义的实验室检查异常 3 有哮喘史的患者 4 诊断为甲状腺功能亢进 5 诊断为阵发性心动过速 6 筛选访视前1 年之内有心肌梗塞史 7 不稳定或危及生命的心率失常 8 过去一年内因心力衰竭住院 9 已知的活动性结核 10 过去五年内患者因恶性肿瘤接受了切除术、放疗或化疗 11 患过危及生命的肺阻塞 12 囊性纤维化病史 13 有临床表现的支气管扩张 14 重要的酒精或药物滥用史 15 进行过胸廓切开术进行肺切除术的患者 16 正在使用β-肾上腺素能口服药物的患者 17 患者正在接受剂量不稳定的口服皮质激素治疗 18 白天定期使用氧气疗法超过每日一小时的患者 19 在筛选访视开始前6 周已完成肺康复计划，或正在进行肺康复计划的患者。 20 在筛选访视之前1 个月或6 个半衰期内（以时间较长者为准）已服用过其它研究药物的患者。 21 已知对β-肾上腺素能药物和/或抗胆碱药、BAC、EDTA等的成分过敏的患者。 22 妊娠或哺乳期女性。 23 未采用高效节育措施的育龄期女性 24 随机化之前不能依从肺部用药限制的患者

试验药

序号 名称 用法 1 中文通用名:噻托溴铵+Olodaterol吸入用固定剂量复方制剂溶液(高剂量组） 用法用量:吸入剂（溶液）；规格：每揿2.5mg/2.5mg（噻托溴铵/Olodaterol)；途径：通过RESPIMAT吸入器（A5）经口吸入，一天一次，每次2揿（早餐给药），用药时程：连续用药52周。 2 中文通用名:噻托溴铵+Olodaterol吸入用固定剂量复方制剂溶液(高剂量组） 用法用量:吸入剂（溶液）;规格：每揿2.5mg/2.5mg（噻托溴铵/Olodaterol);途径：通过RESPIMAT吸入器（A5）经口吸入，一天一次，每次2揿（早餐给药），用药时程：连续用药52周。 3 中文通用名:噻托溴铵+Olodaterol吸入用固定剂量复方制剂溶液（低剂量组） 用法用量:吸入剂（溶液）；规格：每揿1.25mg/2.5mg（噻托溴铵/Olodaterol)；途径：通过RESPIMAT吸入器（A5）经口吸入，一天一次，每次2揿（早餐给药），用药时程：连续用药52周。

对照药

序号 名称 用法 1 中文通用名:Olodaterol吸入剂 用法用量:吸入剂（溶液）；规格：每揿2.5mg（Olodaterol)；途径：通过RESPIMAT吸入器（A5）经口吸入，一天一次，每次2揿（早餐给药），用药时程：连续用药52周。 2 中文通用名:噻托溴铵吸入剂（低剂量） 用法用量:吸入剂（溶液）；规格：每揿1.25mg（噻托溴铵)；途径：通过RESPIMAT吸入器（A5）经口吸入，一天一次，每次2揿（早餐给药），用药时程：连续用药52周。 3 中文通用名:噻托溴铵吸入剂（高剂量） 用法用量:吸入剂（溶液）；规格：每揿1.25mg（噻托溴铵)；途径：通过RESPIMAT吸入器（A5）经口吸入，一天一次，每次2揿（早餐给药），用药时程：连续用药52周。

主要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 FEV1 AUC0-3h 反应情况 24周治疗 有效性指标 2 FEV1 谷值反应情况 24周治疗 有效性指标 3 SGRQ 问卷（总分）。将在汇集本研究和重复研究1237.6 的数据之后对该项终点进行评价。 24周治疗 有效性指标
次要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 TDI 评分（以衡量噻托溴铵加上Olodaterol FDC 对患者健康相关的生活质量的影响）将作为关键的次要终点。与SGRQ 问卷总分一样，该项终点将在合并重复研究1237.6 的数据之后进行评估，评估将在治疗24 周后进行。 24周治疗 有效性指标 2 FVC（用力肺活量）AUC0-3h 反应情况 24周治疗 有效性指标 3 FVC 谷值反应情况 24周治疗 有效性指标 4 12 小时肺功能检查亚组患者中的FEV1 AUC0-12h 反应情况 24周治疗 有效性指标 5 12 小时肺功能检查亚组患者中的FVC AUC0-12h 反应情况 24周治疗 有效性指标 6 FEV1 peak0-3h 反应情况 24周治疗 有效性指标 7 FVC peak0-3h 反应情况 24周治疗 有效性指标

1	姓名	白春学	学位	暂无	职称	教授
	电话	86 18621170011	Email	bai.chunxue@zs-hospital.sh.cn	邮政地址	上海市 徐汇区 枫林路180号 8号楼4层呼吸
	邮编	200032	单位名称	复旦大学附属中山医院

序号	机构名称	主要研究者	国家	省（州）	城市
1	复旦大学附属中山医院	白春学	中国	上海	上海
2	University tsklinikum Mainz	Roland Buhl	Germany	NA	Mainz
3	北京大学第三医院	贺蓓	中国	北京	北京
4	航天中心医院	穆兰	中国	北京	北京
5	江苏省人民医院（南京医科大学第一附属医院）	黄茂	中国	江苏	南京
6	苏州大学附属第一医院	黄建安	中国	江苏	苏州
7	杭州市第一人民医院	王利民	中国	浙江	杭州
8	海南省人民医院	黄奕江	中国	海南	海口
9	华西医院	刘春涛	中国	四川	成都
10	新桥医院 （第三军医大学第二附属医院）	王长征	中国	重庆	重庆
11	第四军医大学附属西京医院	李志奎	中国	陕西	西安
12	沈阳军区总医院	陈萍	中国	辽宁	沈阳
13	山东大学齐鲁医院	肖伟	中国	山东	济南
14	中南大学附属湘雅二医院	陈平	中国	湖南	长沙
15	内蒙古医学院附属医院	付秀华	中国	内蒙古	呼和浩特
16	包头市中心医院	常晓悦	中国	内蒙古	包头
17	首都医科大学北京友谊医院	王浩彦	中国	北京	北京
18	Jambes - PRAC Martinot, J.-B.	Martinot, Jean-Benoit	Belgium	NA	Jambes
19	UZ Leuven - Campus Gasthuisberg	Marc Decramer	Belgium	NA	Leuven
20	Gent - UNIV UZ Gent	Derom, Eric	Belgium	NA	Gent
21	Brussels - UNIV St-Pierre	Ninane, Vincent	Belgium	NA	Bruxelles
22	Liege - HOSP CHR de la Citadelle	Delobbe, Alain	Belgium	NA	Liège
23	Brussels - UNIV UZ Brussel	Vincken, Walter	Belgium	NA	Brussel
24	Oostende - HOSP Henri Serruys	Verhaeghe, Wim	Belgium	NA	Oostende
25	Lebbeke - PRAC Van Zandwehge, L.	Van Zandweghe, Luc	Belgium	B	Lebbeke
26	Turnhout - HOSP AZ Turnhout (St-Elisabeth)	Driesen, Peter	Belgium	NA	Turnhout
27	Arcuri Clinical Research, Philadelphia	Arcuri Kimzey, Nicole	America	PA	Philadelphia
28	Columbus Clinical Research, Columbus	Arora, Samir	America	OH	Columbus
29	MultiCare Pulmonary Specialists, Tacoma	Kahlstrom, Richard	America	WA	Tacoma
30	Clinical Research Institute, Inc, Minneapolis	Berman, Gary	America	MN	Minneapolis
31	Mountain View Clinical Research, Greer	Byars, William	America	CA	Greer
32	Florida Pulmonary Research Institute, LLC, Winter Park	Fakih, Faisal	America	FL	Winter Park
33	Bendel Medical Research Center, LLC, Lafayette	Fei, Richard	America	LA	Lafayette
34	South Carolina Pharmaceutical Research, Spartanburg	Feldman, Gregory	America	SC	Spartanburg
35	Pulmonary Associates of Richmond, Inc, Richmond	Giessel, Glenn	America	VA	Richmond
36	Safe Harbor Clinical Research, East Providence	Gilman, Ronald	America	RI	East Providence
37	New Horizons Clinical Research, Cincinnati	Gottschlich, Gregory	America	OH	Cincinnati
38	Lynn Health Science Institute, Oklahoma City	Griffin, Carl	America	OK	Oklahoma City
39	Clinical Research Institute, Plymouth	Halverson, Philip	America	MN	Plymouth
40	Waterbury Pulmonary Associates, Waterbury	Hill, David	America	CT	Waterbury
41	Avail Clinical Research, LLC, Deland	Hill, John	America	FL	Deland
42	Colorado Health Medical Group - Pulmonology, Fort Collins	Hoyt, James	America	CO	Fort Collins
43	CARE Clinical Research	Hyers, Thomas	America	MO	St. Louis
44	Lowcountry Lung and Critical Care, PA, Charleston	Kaelin, Jr, Thomas	America	SC	Charleston
45	The Clinical Research Center, LLC, St. Louis	Korenblat, Phillip	America	MO	St. Louis
46	Shahrukh Kureishy, MD, McKinney	Kureishy, Shahrukh	America	TX	McKinney
47	Clinical Research of West Florida, Inc, Clearwater	Lynn, Lon	America	FL	Tampa
48	Heart and Lung Associates, PC, Bayside	Mann, Jack	America	NY	Bayside
49	Chesapeake Clinical Research, Inc, Baltimore	Matz, Jonathan	America	MD	Baltimore
50	Clinical Research Advantage, Inc, Henderson	Meli, James	America	NV	Henderson
51	Infinity Medical Research, Inc, North Dartmouth	Mello, Curtis	America	MA	North Dartmouth
52	Western Connecticut Medical Group P.C., Danbury	Oelberg, David	America	CT	Danbury
53	Upstate Pharmaceutical Research, Greenville	Pudi, Krishna	America	SC	Greenville
54	Pulmonary Associates of Richmond Inc, Richmond	Radow, Scott	America	VA	Richmond
55	Pulmonary and Criticial Care of Atlanta, Atlanta	Silverboard, Howard	America	GA	Atlanta
56	American Health Research, Inc, Charlotte	Spangenthal, Selwyn	America	NC	Charlotte
57	Delaware Valley Clinical Research, Marlton	Spirn, Irwin	America	NJ	Marlton
58	Greenville Pharmaceutical Research, Greenville	Abboy, Chandar	America	SC	Greenville
59	M Research of Central Texas, Killeen	Webster, Dave	America	TX	Killeen
60	North Shore Medical Arts, LLP, Great Neck	Karpel, Jill	America	NY	Great Neck
61	CU Pharmaceutical Research, Union	Boscia, Joseph	America	SC	Union
62	Keele Medical Place	Bell, Alan	Canada	ON	Downsview
63	Dr. Anil Dhar Medicine Professional Corporation	Dhar, Anil	Canada	ON	Windsor
64	Primary Care Lung Clinic	D'urzo, Anthony	Canada	ON	Toronto
65	Dynamik Research Inc.	Dowell, Anthony	Canada	QC	Point Claire
66	Q & T Research	Gauthier, Jean Sebastien	Canada	QC	Sherbrooke
67	Moncton Medical Centre	Landry, Daniel	Canada	NB	Moncton
68	Institut universitaire cardiologie-pneumologie de Quebec	Maltais, Francois	Canada	QC	Ste-Foy
69	University of Alberta Hospital	Mayers, Irvin	Canada	AB	Edmonton
70	Co-Medica Research Network Inc.	Ross, David	Canada	ON	Courtice
71	St. Paul's Hospital	Sin, Donald	Canada	BC	Vancouver
72	London Road Diagnostic Clinic	O'Mahony, Michael	Canada	ON	Sarnia
73	Praxis Dr. Haase, 06108 Halle	Haase, Peter-Uwe	Germany	NA	Halle
74	Praxis Dr. Linnhoff, Berlin	Linnhoff, Anneliese	Germany	NA	Berlin
75	Praxis Dr. Naudts, Rodgau	Naudts, Ingomar	Germany	NA	Rodgau/Dudenhofen
76	Praxis Dr. Deckelmann, Leipzig	Deckelmann, Regina	Germany	NA	Leipzig
77	Klinische Forschung Schwerin GmbH	Theis, Elisabeth	Germany	NA	Schwerin
78	Klinische Forschung Hannover Mitte GmbH	Marten, Irmgard	Germany	NA	Hannover
79	Praxis Dr. Rolke, Aschaffenburg	Rolke, Mathias	Germany	NA	Aschaffenburg
80	Praxis Dr. Schlegel, Teuchern	Schlegel, Volker	Germany	NA	Teuchern
81	Hamburger Institut fur Therapieforschung GmbH, Hamburg	Jandl, Margret	Germany	NA	Hamburg
82	Pneum. Forschungsinstitut GmbH am Krankenhaus Grosshansdorf	Watz, Henrik	Germany	NA	Grosshansdorf
83	Medaimun GmbH	Zielen, Stefan	Germany	NA	Frankfurt
84	IKF Pneumologie GmbH & Co. KG	Eich, Andreas	Germany	NA	Frankfurt
85	University tsmedizin der Johannes Gutenberg-Universitatsklinikum Mainz	Korn, Stephanie	Germany	NA	Mainz
86	Ciutat Sanitaria Universitaria de Bellvitge	Salud Santos Pérez	Spain	Spain	Barcelona
87	Hospital de Mérida	Pérez Fernández, Antonio Manuel	Spain	NA	Mérida
88	Hospital Vall d'Hebron	Ferrer, Jaume	Spain	ES	Barcelona
89	Clínica Quirón Madrid	Comeche Casanova, Lorena	Spain	NA	Pozuelo de Alarcón
90	C.A.P. Vic Sud , El Remei	Terns, Manel	Spain	Spain	Vic (Barcelona)
91	Hospital Germans Trias i Pujol. Badalona (Barcelona)	Ruiz Manzano, Juan	Spain	Spain	Badalona (Barcelona)
92	Hospital de la Santa Cruz y San Pablo	Ramos Barbón, David	Spain	E	Barcelona
93	Hospital General Universitario de Alicante	Signes-Costa, Jaime	Spain	Spain	San Juan de Alicante
94	National Allergy Asthma Bronchitis Institute, Kolkata	Ghoshal, Aloke Gopal	India	NA	Kolkatta
95	Chest Research Centre	Balamurugan, S.	India	NA	Chennai
96	Navkar Hospital	Jain, Manish	India	NA	Jaipur
97	Bhatia Hospital	Rajan, Sujeet	India	NA	Mumbai
98	Getwell Hospital & Research Institute	Swarnakar, Rajesh	India	NA	Maharastra
99	K.E.M Hospital	Khatavkar, Parag	India	NA	Pune
100	Curie Manavata Cancer centre	Mutha, B.K.	India	NA	Nashik, Maharashtra
101	Bala Medical Center and Hospital	Krishnamurthy, Srikanth	India	NA	Coimbatore
102	Hokkaido Univ., Hokkaido, Intl. Med. I	Nagai, Katsura	Japan	NA	Kita-ku, Sapporo, Hokkaido
103	Hokkaidoh Chuo Rosai Hp., Hokkaido, I.M.	Ohtsuka, Yoshinori	Japan	NA	Iwamizawa, Hokkaido
104	Hokkaido Social Insurance Hp., Hokkaido, Ctr for Resp. Dis.	Harada, Toshiyuki	Japan	NA	Sapporo, Hokkaido
105	Obihiro Kokyukika Naika Hp., Hokkaido, RESP I.M.	Sugawara, Yoshitaka	Japan	NA	Obihiro, Hokkaido
106	Mito Kyodo Gen. Hp., Ibaraki, Resp. I.M.	Satoh, Hiroaki	Japan	NA	Mito, Ibaraki
107	Hitachi Gen. Hp., Ibaraki, I.M.	Nawa, Takeshi	Japan	NA	Hitachi, Ibaraki
108	Soka I.M. And RESP Care Clinic, Saitama, Resp. Med.	Atarashi, Kenichi	Japan	NA	Soka, Saitama
109	Otakanomori Hp., Chiba, RESP	Matsukura, Akira	Japan	NA	Kashiwa, Chiba
110	Tokyo Med. Univ. Hachioji Med. Ctr, Tokyo, Resp. Med.	Ichiwata, Toshio	Japan	NA	Hachioji, Tokyo
111	Denenchofu RESP & I.M. Clinic, Tokyo, Resp. I.M.	Kiyokawa, Hiroshi	Japan	NA	Ota-ku, Tokyo
112	Keio Univ., School of Med., Tokyo, RESR Med.	Betsuyaku, Tomoko	Japan	NA	Shinjuku-ku, Tokyo
113	Kyorin Univ. Hp., Tokyo, Dep. of Resp. Med.	Wada, Hiroo	Japan	NA	Mitaka, Tokyo
114	Yokohama City Univ. Hp., Kanagawa, Resp. Med.	Sasaki, Masahiro	Japan	NA	Kanazawa, Yokohama, Kanagawa
115	Kokan Clinic, Kanagawa, I.M.	Miyao, Naoki	Japan	NA	Kawasaki-ku, Kawasaki, Kanagawa
116	Kamimutsukawa Clinic, Kanagawa, PULM	Mishima, Wataru	Japan	NA	Minami-ku, Yokohama, Kanagawa
117	Shonankamakura Gen. Hp., Kanagawa, RESP I.M.	Takahashi, Yasuhiro	Japan	NA	Kamakura, Kanagawa
118	Yokohama City Univ. Med. Ctr, Kanagawa, Resp. Disease Ctr	Shinkai, Masaharu	Japan	NA	Minami-ku, Yokohama, Kanagawa
119	Yokosuka General Hp. Uwamachi, Kanagawa, PULM Med.	Miura, Hirotaro	Japan	NA	Yokosuka, Kanagawa
120	Ishikawa Pref. Ctr Hp., Ishikawa, Resp. Med.	Nishi, Koichi	Japan	NA	Kanazawa, Ishikawa
121	Fukui Pref. Hp., Fukui, Resp. Med.	Kojima, Toru	Japan	NA	Fukui, Fukui
122	Takayama Red Cross Hp., Gifu, Dep. of I.M.	Hosoe, Atsunori	Japan	NA	Takayama, Gifu
123	Shizuoka Pref Gen. Hp., Shizuoka, Resp. Med.	Shirai, Toshihiro	Japan	NA	Aoi-ku, Shizuoka, Shizuoka
124	Uji Tokushukai Hp., Kyoto, I.M.	Saito, Masahiko	Japan	NA	Uji, Kyoto
125	Sasaki Clinic, Osaka, Resp. Med.	Sasaki, Norihisa	Japan	NA	Kita-ku, Sakai, Osaka
126	Osaka City Univ. Hp., Osaka, RESR Med.	Tochino, Yoshihiro	Japan	NA	Abeno-ku, Osaka, Osaka
127	Toyonaka Midorigaoka Hp., Osaka, I.M.	Otani, Ichiro	Japan	NA	Toyonaka, Osaka
128	Yao Tokushukai Gen. Hp., Osaka, Dep. of Med.	Harada, Hiromasa	Japan	NA	Yao, Osaka
129	Yoka Hp., Hyogo, Resp. Med.	Shiota, Tetsuhiro	Japan	NA	Yabu, Hyogo
130	Nishi-kobe Med. Ctr, Hyogo, Resp. Med.	Ikeda, Akihiko	Japan	NA	Nishi-ku, Kobe, Hyogo
131	Kobe City Med. Ctr Gen. Hp., Hyogo, Resp. Med.	Tomii, Keisuke	Japan	NA	Chuo-ku, Kobe, Hyogo
132	Takarazuka City Hp., Hyogo, Dep. of Resr. Med.	Takenaka, Masahiko	Japan	NA	Takarazuka, Hyogo
133	Nakatani Hp., Hyogo, I.M.	Nakatani, Yuji	Japan	NA	Himeji, Hyogo
134	Kawasaki Hp. Kawasaki Med. Sch., Okayama, I.M.	Okimoto, Niro	Japan	NA	Kita-ku, Okayama, Okayama
135	Kurashiki City Kojima Hp.,Okayama, I.M.	Eda, Ryosuke	Japan	NA	Kurashiki, Okayama
136	Chugoku Ctr Hp., Hiroshima, I.M.	Harita, Shingo	Japan	NA	Fukuyama, Hiroshima
137	Sakaide City Hp., Kagawa, I.M.	Nakamura, Hiroyuki	Japan	NA	Sakaide, Kagawa
138	Iizuka Hp., Fukuoka, Resp. Med.	Ebi, Noriyuki	Japan	NA	Iizuka, Fukuoka
139	Okinawa Pref Nanbu Med Ct&Children Med Ct, Okinawa, Resp Med	Azuma, Masato	Japan	NA	Shimajiri-gun, Okinawa
140	Chibana Clinic, Okinawa, Resp. Med.	Ishimine, Tomohiko	Japan	NA	Okinawa, Okinawa
141	Naha City Hp., Okinawa, I.M.	Kyan, Yukio	Japan	NA	Naha, Okinawa
142	Tomishiro Ctr Hp, Okinawa, Resp. Med.	Matsumoto, Tsuyoshi	Japan	NA	Tomigusuku, Okinawa
143	Nanbu Tokushukai Hp., Okinawa, Dep. of Thoracic Surgery	Shimoji, Mitsuyoshi	Japan	NA	Shimajiri-gun, Okinawa
144	National Ctr for Global Health and Med., Tokyo, Resp. Med.	Izumi, Shinyu	Japan	NA	Shinjuku-ku, Tokyo
145	Flattum Legesenter, Honefoss	Gronert, Jorn Ossum	Norway	NA	Honefoss
146	Dr. Thomas Karlsson, Klofta	Karlsson, Thomas	Norway	NA	Klofta
147	Oslo Barne- og Lungelegesenter, Oslo	Myhr, Leiv	Norway	NA	Oslo
148	Norsk Helseklinikk AS, Lierskogen	Solnor, Leidulv	Norway	NA	Lierskogen
149	Medi 3 Innlandet AS, avd Elverum	Elle, Sigbjorn	Norway	NA	Elverum
150	Ski Spesialistsenter, Ski	Borge, Lars	Norway	NA	Ski
151	Svelvik Legesenter, Svelvik	Tomala, Tadeusz	Norway	NA	Svelvik
152	Hospital Nossa Senhora da Conceicao	Mattos, Waldo Luis Leite Dias	Brazil	RS	Porto Alegre
153	Hospital Sao Lucas da PUCRS	Fritscher, Carlos Cezar	Brazil	RS	Porto Alegre
154	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Rubin, Adalberto Sperb	Brazil	RS	Porto Alegre
155	Associacao Hospitalar Moinhos de Vento	Do Valle, Enio Luiz Tschiedel	Brazil	RS	Porto Alegre
156	Lar Escola Sao Francisco	Jardim, José Roberto Brito	Brazil	SP	Sao Paulo
157	Centro de Pesquisa Clinica - CPCLIN	Lastebasse, Flavio Gnecco	Brazil	BR	Sao Paulo
158	Hospital de Clínicas de Porto Alegre	Knorst, Marli	Brazil	RS	Porto Alegre
159	Hospital Universitario da Univers. Federal de Santa Catarina	Pizzichini, Emilio	Brazil	SC	Florianopolis
160	Hospital das Clínicas de Sao Paulo - INCOR	Cukier, Alberto	Brazil	SP	Sao Paulo
161	Hospital Sao Vicente de Paulo	Mello, Danuza Avila	Brazil	RS	Passo Fundo
162	Hospital das Clinicas de Botucatu	Minamoto, Suzana Erico Tanni	Brazil	SP	Botucatu
163	Fundacion Clinica Shaio	Severiche, Diego	Columbia	Bogota	Bogota DC
164	Centro Especializado en Enfermedades Pulmonares	Matiz, Carlos	Columbia	Bogota	Bogota DC
165	Fundación Oftalmologica de Santander	Bolivar, Fabio	Columbia	Santander	Floridablanca
166	Fundación Valle del Lili	Fernandez, Liliana	Columbia	Valle Cauc	Cali
167	Hospital Santa Clara E.S.E.	Serrano, Francisco	Columbia	Bogota	Bogota DC
168	Fundacao Neumologica Colombiana	Conde, Rafael	Columbia	NA	Bogota
169	National Taiwan University Hospital	Kuo, Ping-Hung	中国	NA	Taipei
170	Far Eastern Memorial Hospital	Cheng, Shih-Lung	中国	NA	New Taipei City
171	Chang Gung Memorial Hospital	Yang, Cheng-Ta	中国	NA	Taoyuan County
172	China Medical University Hospital	Hang, Liang-Wen	中国	NA	Taichung
173	National Cheng Kung University Hospital	Hsiue, Tzuen-Ren	中国	NA	Tainan
174	Chang Gung Memorial Hospital Kaohsiung	Wang, Chin-Chou	中国	NA	Kaohsiung City
175	E-Da Hospital	Wei, Yu-Feng	中国	NA	Kaohsiung
176	KH der Elisabethinen Linz, Abt. Pneumologie	Bolitschek, Josef	Austria	NA	Linz
177	Univ.-Klinik für Innere Medizin Innsbruck	Kahler, Christian Matthias	Austria	NA	Innsbruck
178	LKH Salzburg - Universitatsklinik für Pneumologie	Studnicka, Michael	Austria	NA	Salzburg
179	Ordination Dr. Flicker c/o Arbeitsmed.Zentrum d.Voest Alpine	Flicker, Martin	Austria	NA	Leoben
180	Ordination Dr. Wolfgang Pohl, 2230 Ganserndorf	Pohl, Wolfgang	Austria	NA	Ganserndorf
181	Ordination Dr. Robert Voves, 8330 Feldbach	Voves, Robert	Austria	NA	Feldbach
182	University of Debrecen	Szilasi, Maria	Hungary	NA	Debrecen
183	Institute of Chest Diseases of Csongrad, Szeged	Balint, Beatrix	Hungary	NA	Szeged
184	Erzsebet Hospital Sopron	Bartfai, Zoltan	Hungary	NA	Sopron
185	Tormay Karoly Health Center, Godollo	Mucsi, Janos	Hungary	NA	Godollo
186	United Institutes of Public Health, Pecs	Varga, Agnes	Hungary	NA	Pecs
187	Hospital for Pulmonary Diseases, Zagreb	Glad, Ljerka	Croatia	NA	Zagreb
188	General Hosp. Zadar, Dept. of Internal Medicine-Pulmonology	Sinovcic-Kolanovic, Suzana	Croatia	NA	Zadar
189	General Hosp.	Stjepanovic, Gordana	Croatia	NA	Petrinja
190	Clincal Hospital Centre Rijeka	Matanic, Dubravka	Croatia	NA	Rijeka
191	Emergency Clinical Hospital n. a. N. V. Soloviev, Yaroslavl	Palyutin, Shamil	Russia	NA	Yaroslavl
192	State Medical University	Trofimov, Vasiliy	Russia	NA	St. Petersburg
193	Medical Research Institute LLC, St. Petersburg	Stitsenko, Irina A.	Russia	NA	St. Petersburg
194	GUZ City Clinical Hospital no. 7, Moscow	Sidorenko, Irina	Russia	NA	Moscow
195	City Clinical Hospital no. 12, Moscow	Karabinenko, Alexandr	Russia	NA	Moscow
196	Quantum Medical Center, Bucharest	Tudorache, Mirela	Romania	NA	Bucharest
197	Centrul Medical SANA, Bucuresti	Popescu, Elena	Romania	NA	Bucuresti
198	Spitalul Clinic de Pneumoftizologie Leon Daniello, Cluj	Todea, Doina A	Romania	NA	Cluj
199	Emergency Clin. County Hosp. Pneumology Dept.	Nini, Georghe	Romania	NA	Arad
200	Dr. Dana Olar Praxis Ltd., Pneumology	Olar, Dana	Romania	NA	Arad
201	St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov	Lescisinova, Helena	Slovakia	NA	Bardejov
202	Pulmo-Medik s.r.o. Outpatient Clinic of Pneumology	KUBIKOVA, Yveta	Slovakia	NA	Bojnice
203	Plucna Ambulancia Hrebenar s.r.o.	Hrebenar, Slavomir	Slovakia	NA	Spisska Nova Ves
204	Medipobcom s.r.o.	Pobehova, Maria	Slovakia	NA	Kosice
205	Faculty Hospital Zilina, Outpatient Clinic of Pneumology	Paluchova, Maria	Slovakia	NA	Zilina
206	Imunoalergologia Dr. Dzurilla s.r.o.	Dzurilla, Martin	Slovakia	NA	Nitra
207	Clinic for Pulmonary Diseases and TBC Knez Selo	Stankovic, Ivana	Serbia	NA	Nis
208	Centre for Pulmonary Diseases Kragujevac	Lazic, Zorica	Serbia	NA	Kragujevac
209	Institute for Pulmonary Diseases and TBC,CCS	Milikic, Marija Mitic	Serbia	NA	Belgrade
210	Institute for Pulmonary Diseases and TBC,CCS	Milenkovic, Branislava	Serbia	NA	Belgrade
211	Clinical Hospital Center	Vukcevic, Miodrag	Serbia	NA	Belgrade
212	Skanes universitetssjukhus, Lund	Bjermer, Leif	Sweden	NA	Lund
213	Me3 plus clinical trials, Goteborg	Curiac, Dan	Sweden	NA	Goteborg
214	Bjorknas Vardcentral, Boden	Lindberg, Anne	Sweden	NA	Boden
215	Karolinska Universitetssjukhuset, Solna	Skold, Magnus	Sweden	NA	Stockholm
216	Nasets lakargrupp, Hollviken	Romberg, Kerstin	Sweden	NA	Hollviken
217	Sjukhuset, Harnosand	Kempe, Anders	Sweden	NA	Harnosand
218	Vardcentralen Silentzvagen, Uddevalla	Polhem, Bo	Sweden	NA	Uddevalla
219	Ege Universitesi Tip Fakultesi Gogüs Hastaliklari ABD	Sayiner, Abdullah	Turkey	NA	Izmir
220	Dr. Suat Seren Gogus Has ve Gogus Cerrahisi Egit ve Aras Has	Guclu, Salih Zeki	Turkey	NA	Izmir
221	Pamukkale Universitesi Tip Fakultesi Hastanesi	Evyapan, Fatma	Turkey	NA	Denizli
222	Bezmi Alem Vakif Universitesi Tip Fakultesi Hastanesi	Kart, Levent	Turkey	NA	Istanbul
223	Ankara Universitesi Tip Fakultesi Cebeci Has.Gogus Has.ABD	Yildiz, Oznur	Turkey	NA	Ankara
224	Wythenshawe Hospital, The Medicines Evaluation Unit	Singh, Dave	Great Britain	NA	Manchester
225	Waterloo Medical Centre, Blackpool	Calvert, John	Great Britain	NA	Blackpool
226	Bristol Royal Infirmary, Respiratory Dept.	Jarad, Dr Nabil	Great Britain	NA	Bristol
227	St Chad's Surgery, Midsomer Norton	Jones, Nick	Great Britain	Avon	Midsomer Norton
228	Layton Medical Centre, Blackpool	Kerrane, Jerome	Great Britain	NA	Blackpool
229	St Peter's Hospital, Dept of Respiratory Medicine	Nordstrom, Monica	Great Britain	Surrey	Chertsey
230	Belle Vue Surgery, Fleetwood	Ramesh, Dr Cobarsanellore	Great Britain	NA	Fleetwood
231	St. Vincent's University Hospital, Respiratory Dept.	Butler, Marcus W	Ireland	NA	Dublin
232	The Adelaide & Meath Hospital, Dept of Respiratory Medicine	Lane, Stephen	Ireland	NA	Dublin
233	Mid-Western Regional Hospital, Respiratory Medicine	O'Brien, Aidan	Ireland	NA	County Limerick
234	UCT Lung Institute: Respiratory	Bateman, Eric	South Africa	NA	Cape Town
235	Tiervlei Trial Centre	Joubert, James Rattray	South Africa	NA	Bellville
236	Gatesville Medical Centre 308	Abdullah, Ismail	South Africa	NA	Cape Town
237	H08 Panorama Medi-Clinic	Richter, Daphne	South Africa	NA	Cape Town
238	Pretoria East Hospital	Ras, Gerhard	South Africa	NA	Pretoria
239	Henry D. Covelli, MD	Covelli, Henry	America	ID	Couer d'Alene
240	Lovelace Scientific Resources	Dorf, Jeffrey	America	NM	Albuquerque
241	Rowan Research Inc	Lochner, Jerrel	America	WA	Spokane

序号	名称	审查结论	批准日期/备案日期
1	复旦大学附属中山医院伦理委员会	同意	2012-03-22

已完成

目标入组人数	国内: 275 ； 国际: 2500 ；
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: 292  ； 国际: 2519 ；

第一例受试者签署知情同意书日期	国内：2012-03-29；     国际：2010-09-15；
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：2013-12-09；     国际：2013-12-09；