登记号
CTR20131479
相关登记号
CTR20131478
曾用名
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
试验方案编号
1237.6
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
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
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
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
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
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
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
- COPD患者
- 患者的气道阻塞必须相对稳定，使用支气管扩张剂后FEV1<预计正常值的80 ％， 并且使用支气管扩张剂后FEV1/FVC <70％
- 年龄40 岁或以上的男性、女性患者
- 患者目前吸烟，或者有吸烟史（超过10 包年）
排除标准
- 受试者除了患有COPD 外还患有其它重大疾病
- 有临床意义的实验室检查异常
- 有哮喘史的患者
- 诊断为甲状腺功能亢进
- 诊断为阵发性心动过速
- 筛选访视前1 年之内有心肌梗塞史
- 不稳定或危及生命的心率失常
- 过去一年内因心力衰竭住院
- 已知的活动性结核
- 过去五年内患者因恶性肿瘤接受了切除术、放疗或化疗
- 患过危及生命的肺阻塞
- 囊性纤维化病史
- 有临床表现的支气管扩张
- 重要的酒精或药物滥用史
- 进行过胸廓切开术进行肺切除术的患者
- 正在使用β-肾上腺素能口服药物的患者
- 患者正在接受剂量不稳定的口服皮质激素治疗
- 白天定期使用氧气疗法超过每日一小时的患者
- 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。
- 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。
- 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。
- 妊娠或哺乳期女性。
- 未采用高效节育措施的育龄期女性
- 随机化之前不能依从肺部用药限制的患者
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
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。
|
|
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。
|
|
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
| 名称 | 用法 |
|---|---|
|
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。
|
|
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。
|
|
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。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| FEV1 AUC0-3h 反应情况 | 24周治疗 | 有效性指标 |
| FEV1 谷值反应情况 | 24周治疗 | 有效性指标 |
| 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
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 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 |
| FVC（用力肺活量）AUC0-3h 反应情况 | 24周治疗 | 有效性指标 |
| FVC 谷值反应情况 | 24周治疗 | 有效性指标 |
| 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 |
| 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 |
| FEV1 peak0-3h 反应情况 | 24周治疗 | 有效性指标 |
| FVC peak0-3h 反应情况 | 24周治疗 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 白春学 | 教授 | 86 18621170011 | bai.chunxue@zs-hospital.sh.cn | 上海市 徐汇区 枫林路180号 8号楼4层呼吸 | 200032 | 复旦大学附属中山医院 | |
| Roland Buhl | 教授，医学博士 | 49 6131 17 7271 | Roland.Buhl@unimedizin-mainz.de | Langenbeckstrasse 1 D-55131 美因茨 德国 | 55131 | 美因茨约翰内斯堡古腾堡大学 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 复旦大学附属中山医院 | 白春学 | 中国 | 上海 | 上海 |
| University tsklinikum Mainz | Roland Buhl | Germany | NA | Mainz |
| 北京大学第三医院 | 贺蓓 | 中国 | 北京 | 北京 |
| 航天中心医院 | 穆兰 | 中国 | 北京 | 北京 |
| 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 |
| 苏州大学附属第一医院 | 黄建安 | 中国 | 江苏 | 苏州 |
| 杭州市第一人民医院 | 王利民 | 中国 | 浙江 | 杭州 |
| 海南省人民医院 | 黄奕江 | 中国 | 海南 | 海口 |
| 华西医院 | 刘春涛 | 中国 | 四川 | 成都 |
| 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 |
| 第四军医大学附属西京医院 | 李志奎 | 中国 | 陕西 | 西安 |
| 沈阳军区总医院 | 陈萍 | 中国 | 辽宁 | 沈阳 |
| 山东大学齐鲁医院 | 肖伟 | 中国 | 山东 | 济南 |
| 中南大学附属湘雅二医院 | 陈平 | 中国 | 湖南 | 长沙 |
| 内蒙古医学院附属医院 | 付秀华 | 中国 | 内蒙古 | 呼和浩特 |
| 包头市中心医院 | 常晓悦 | 中国 | 内蒙古 | 包头 |
| 首都医科大学北京友谊医院 | 王浩彦 | 中国 | 北京 | 北京 |
| Jambes - PRAC Martinot, J.-B. | Martinot, Jean-Benoit | Belgium | NA | Jambes |
| UZ Leuven - Campus Gasthuisberg | Marc Decramer | Belgium | NA | Leuven |
| Gent - UNIV UZ Gent | Derom, Eric | Belgium | NA | Gent |
| Brussels - UNIV St-Pierre | Ninane, Vincent | Belgium | NA | Bruxelles |
| Liege - HOSP CHR de la Citadelle | Delobbe, Alain | Belgium | NA | Liège |
| Brussels - UNIV UZ Brussel | Vincken, Walter | Belgium | NA | Brussel |
| Oostende - HOSP Henri Serruys | Verhaeghe, Wim | Belgium | NA | Oostende |
| Lebbeke - PRAC Van Zandwehge, L. | Van Zandweghe, Luc | Belgium | B | Lebbeke |
| Turnhout - HOSP AZ Turnhout (St-Elisabeth) | Driesen, Peter | Belgium | NA | Turnhout |
| Arcuri Clinical Research, Philadelphia | Arcuri Kimzey, Nicole | America | PA | Philadelphia |
| Columbus Clinical Research, Columbus | Arora, Samir | America | OH | Columbus |
| MultiCare Pulmonary Specialists, Tacoma | Kahlstrom, Richard | America | WA | Tacoma |
| Clinical Research Institute, Inc, Minneapolis | Berman, Gary | America | MN | Minneapolis |
| Mountain View Clinical Research, Greer | Byars, William | America | CA | Greer |
| Florida Pulmonary Research Institute, LLC, Winter Park | Fakih, Faisal | America | FL | Winter Park |
| Bendel Medical Research Center, LLC, Lafayette | Fei, Richard | America | LA | Lafayette |
| South Carolina Pharmaceutical Research, Spartanburg | Feldman, Gregory | America | SC | Spartanburg |
| Pulmonary Associates of Richmond, Inc, Richmond | Giessel, Glenn | America | VA | Richmond |
| Safe Harbor Clinical Research, East Providence | Gilman, Ronald | America | RI | East Providence |
| New Horizons Clinical Research, Cincinnati | Gottschlich, Gregory | America | OH | Cincinnati |
| Lynn Health Science Institute, Oklahoma City | Griffin, Carl | America | OK | Oklahoma City |
| Clinical Research Institute, Plymouth | Halverson, Philip | America | MN | Plymouth |
| Waterbury Pulmonary Associates, Waterbury | Hill, David | America | CT | Waterbury |
| Avail Clinical Research, LLC, Deland | Hill, John | America | FL | Deland |
| Colorado Health Medical Group - Pulmonology, Fort Collins | Hoyt, James | America | CO | Fort Collins |
| CARE Clinical Research | Hyers, Thomas | America | MO | St. Louis |
| Lowcountry Lung and Critical Care, PA, Charleston | Kaelin, Jr, Thomas | America | SC | Charleston |
| The Clinical Research Center, LLC, St. Louis | Korenblat, Phillip | America | MO | St. Louis |
| Shahrukh Kureishy, MD, McKinney | Kureishy, Shahrukh | America | TX | McKinney |
| Clinical Research of West Florida, Inc, Clearwater | Lynn, Lon | America | FL | Tampa |
| Heart and Lung Associates, PC, Bayside | Mann, Jack | America | NY | Bayside |
| Chesapeake Clinical Research, Inc, Baltimore | Matz, Jonathan | America | MD | Baltimore |
| Clinical Research Advantage, Inc, Henderson | Meli, James | America | NV | Henderson |
| Infinity Medical Research, Inc, North Dartmouth | Mello, Curtis | America | MA | North Dartmouth |
| Western Connecticut Medical Group P.C., Danbury | Oelberg, David | America | CT | Danbury |
| Upstate Pharmaceutical Research, Greenville | Pudi, Krishna | America | SC | Greenville |
| Pulmonary Associates of Richmond Inc, Richmond | Radow, Scott | America | VA | Richmond |
| Pulmonary and Criticial Care of Atlanta, Atlanta | Silverboard, Howard | America | GA | Atlanta |
| American Health Research, Inc, Charlotte | Spangenthal, Selwyn | America | NC | Charlotte |
| Delaware Valley Clinical Research, Marlton | Spirn, Irwin | America | NJ | Marlton |
| Greenville Pharmaceutical Research, Greenville | Abboy, Chandar | America | SC | Greenville |
| M Research of Central Texas, Killeen | Webster, Dave | America | TX | Killeen |
| North Shore Medical Arts, LLP, Great Neck | Karpel, Jill | America | NY | Great Neck |
| CU Pharmaceutical Research, Union | Boscia, Joseph | America | SC | Union |
| Keele Medical Place | Bell, Alan | Canada | ON | Downsview |
| Dr. Anil Dhar Medicine Professional Corporation | Dhar, Anil | Canada | ON | Windsor |
| Primary Care Lung Clinic | D'urzo, Anthony | Canada | ON | Toronto |
| Dynamik Research Inc. | Dowell, Anthony | Canada | QC | Point Claire |
| Q & T Research | Gauthier, Jean Sebastien | Canada | QC | Sherbrooke |
| Moncton Medical Centre | Landry, Daniel | Canada | NB | Moncton |
| Institut universitaire cardiologie-pneumologie de Quebec | Maltais, Francois | Canada | QC | Ste-Foy |
| University of Alberta Hospital | Mayers, Irvin | Canada | AB | Edmonton |
| Co-Medica Research Network Inc. | Ross, David | Canada | ON | Courtice |
| St. Paul's Hospital | Sin, Donald | Canada | BC | Vancouver |
| London Road Diagnostic Clinic | O'Mahony, Michael | Canada | ON | Sarnia |
| Praxis Dr. Haase, 06108 Halle | Haase, Peter-Uwe | Germany | NA | Halle |
| Praxis Dr. Linnhoff, Berlin | Linnhoff, Anneliese | Germany | NA | Berlin |
| Praxis Dr. Naudts, Rodgau | Naudts, Ingomar | Germany | NA | Rodgau/Dudenhofen |
| Praxis Dr. Deckelmann, Leipzig | Deckelmann, Regina | Germany | NA | Leipzig |
| Klinische Forschung Schwerin GmbH | Theis, Elisabeth | Germany | NA | Schwerin |
| Klinische Forschung Hannover Mitte GmbH | Marten, Irmgard | Germany | NA | Hannover |
| Praxis Dr. Rolke, Aschaffenburg | Rolke, Mathias | Germany | NA | Aschaffenburg |
| Praxis Dr. Schlegel, Teuchern | Schlegel, Volker | Germany | NA | Teuchern |
| Hamburger Institut fur Therapieforschung GmbH, Hamburg | Jandl, Margret | Germany | NA | Hamburg |
| Pneum. Forschungsinstitut GmbH am Krankenhaus Grosshansdorf | Watz, Henrik | Germany | NA | Grosshansdorf |
| Medaimun GmbH | Zielen, Stefan | Germany | NA | Frankfurt |
| IKF Pneumologie GmbH & Co. KG | Eich, Andreas | Germany | NA | Frankfurt |
| University tsmedizin der Johannes Gutenberg-Universitatsklinikum Mainz | Korn, Stephanie | Germany | NA | Mainz |
| Ciutat Sanitaria Universitaria de Bellvitge | Salud Santos Pérez | Spain | Spain | Barcelona |
| Hospital de Mérida | Pérez Fernández, Antonio Manuel | Spain | NA | Mérida |
| Hospital Vall d'Hebron | Ferrer, Jaume | Spain | ES | Barcelona |
| Clínica Quirón Madrid | Comeche Casanova, Lorena | Spain | NA | Pozuelo de Alarcón |
| C.A.P. Vic Sud , El Remei | Terns, Manel | Spain | Spain | Vic (Barcelona) |
| Hospital Germans Trias i Pujol. Badalona (Barcelona) | Ruiz Manzano, Juan | Spain | Spain | Badalona (Barcelona) |
| Hospital de la Santa Cruz y San Pablo | Ramos Barbón, David | Spain | E | Barcelona |
| Hospital General Universitario de Alicante | Signes-Costa, Jaime | Spain | Spain | San Juan de Alicante |
| National Allergy Asthma Bronchitis Institute, Kolkata | Ghoshal, Aloke Gopal | India | NA | Kolkatta |
| Chest Research Centre | Balamurugan, S. | India | NA | Chennai |
| Navkar Hospital | Jain, Manish | India | NA | Jaipur |
| Bhatia Hospital | Rajan, Sujeet | India | NA | Mumbai |
| Getwell Hospital & Research Institute | Swarnakar, Rajesh | India | NA | Maharastra |
| K.E.M Hospital | Khatavkar, Parag | India | NA | Pune |
| Curie Manavata Cancer centre | Mutha, B.K. | India | NA | Nashik, Maharashtra |
| Bala Medical Center and Hospital | Krishnamurthy, Srikanth | India | NA | Coimbatore |
| Hokkaido Univ., Hokkaido, Intl. Med. I | Nagai, Katsura | Japan | NA | Kita-ku, Sapporo, Hokkaido |
| Hokkaidoh Chuo Rosai Hp., Hokkaido, I.M. | Ohtsuka, Yoshinori | Japan | NA | Iwamizawa, Hokkaido |
| Hokkaido Social Insurance Hp., Hokkaido, Ctr for Resp. Dis. | Harada, Toshiyuki | Japan | NA | Sapporo, Hokkaido |
| Obihiro Kokyukika Naika Hp., Hokkaido, RESP I.M. | Sugawara, Yoshitaka | Japan | NA | Obihiro, Hokkaido |
| Mito Kyodo Gen. Hp., Ibaraki, Resp. I.M. | Satoh, Hiroaki | Japan | NA | Mito, Ibaraki |
| Hitachi Gen. Hp., Ibaraki, I.M. | Nawa, Takeshi | Japan | NA | Hitachi, Ibaraki |
| Soka I.M. And RESP Care Clinic, Saitama, Resp. Med. | Atarashi, Kenichi | Japan | NA | Soka, Saitama |
| Otakanomori Hp., Chiba, RESP | Matsukura, Akira | Japan | NA | Kashiwa, Chiba |
| Tokyo Med. Univ. Hachioji Med. Ctr, Tokyo, Resp. Med. | Ichiwata, Toshio | Japan | NA | Hachioji, Tokyo |
| Denenchofu RESP & I.M. Clinic, Tokyo, Resp. I.M. | Kiyokawa, Hiroshi | Japan | NA | Ota-ku, Tokyo |
| Keio Univ., School of Med., Tokyo, RESR Med. | Betsuyaku, Tomoko | Japan | NA | Shinjuku-ku, Tokyo |
| Kyorin Univ. Hp., Tokyo, Dep. of Resp. Med. | Wada, Hiroo | Japan | NA | Mitaka, Tokyo |
| Yokohama City Univ. Hp., Kanagawa, Resp. Med. | Sasaki, Masahiro | Japan | NA | Kanazawa, Yokohama, Kanagawa |
| Kokan Clinic, Kanagawa, I.M. | Miyao, Naoki | Japan | NA | Kawasaki-ku, Kawasaki, Kanagawa |
| Kamimutsukawa Clinic, Kanagawa, PULM | Mishima, Wataru | Japan | NA | Minami-ku, Yokohama, Kanagawa |
| Shonankamakura Gen. Hp., Kanagawa, RESP I.M. | Takahashi, Yasuhiro | Japan | NA | Kamakura, Kanagawa |
| Yokohama City Univ. Med. Ctr, Kanagawa, Resp. Disease Ctr | Shinkai, Masaharu | Japan | NA | Minami-ku, Yokohama, Kanagawa |
| Yokosuka General Hp. Uwamachi, Kanagawa, PULM Med. | Miura, Hirotaro | Japan | NA | Yokosuka, Kanagawa |
| Ishikawa Pref. Ctr Hp., Ishikawa, Resp. Med. | Nishi, Koichi | Japan | NA | Kanazawa, Ishikawa |
| Fukui Pref. Hp., Fukui, Resp. Med. | Kojima, Toru | Japan | NA | Fukui, Fukui |
| Takayama Red Cross Hp., Gifu, Dep. of I.M. | Hosoe, Atsunori | Japan | NA | Takayama, Gifu |
| Shizuoka Pref Gen. Hp., Shizuoka, Resp. Med. | Shirai, Toshihiro | Japan | NA | Aoi-ku, Shizuoka, Shizuoka |
| Uji Tokushukai Hp., Kyoto, I.M. | Saito, Masahiko | Japan | NA | Uji, Kyoto |
| Sasaki Clinic, Osaka, Resp. Med. | Sasaki, Norihisa | Japan | NA | Kita-ku, Sakai, Osaka |
| Osaka City Univ. Hp., Osaka, RESR Med. | Tochino, Yoshihiro | Japan | NA | Abeno-ku, Osaka, Osaka |
| Toyonaka Midorigaoka Hp., Osaka, I.M. | Otani, Ichiro | Japan | NA | Toyonaka, Osaka |
| Yao Tokushukai Gen. Hp., Osaka, Dep. of Med. | Harada, Hiromasa | Japan | NA | Yao, Osaka |
| Yoka Hp., Hyogo, Resp. Med. | Shiota, Tetsuhiro | Japan | NA | Yabu, Hyogo |
| Nishi-kobe Med. Ctr, Hyogo, Resp. Med. | Ikeda, Akihiko | Japan | NA | Nishi-ku, Kobe, Hyogo |
| Kobe City Med. Ctr Gen. Hp., Hyogo, Resp. Med. | Tomii, Keisuke | Japan | NA | Chuo-ku, Kobe, Hyogo |
| Takarazuka City Hp., Hyogo, Dep. of Resr. Med. | Takenaka, Masahiko | Japan | NA | Takarazuka, Hyogo |
| Nakatani Hp., Hyogo, I.M. | Nakatani, Yuji | Japan | NA | Himeji, Hyogo |
| Kawasaki Hp. Kawasaki Med. Sch., Okayama, I.M. | Okimoto, Niro | Japan | NA | Kita-ku, Okayama, Okayama |
| Kurashiki City Kojima Hp.,Okayama, I.M. | Eda, Ryosuke | Japan | NA | Kurashiki, Okayama |
| Chugoku Ctr Hp., Hiroshima, I.M. | Harita, Shingo | Japan | NA | Fukuyama, Hiroshima |
| Sakaide City Hp., Kagawa, I.M. | Nakamura, Hiroyuki | Japan | NA | Sakaide, Kagawa |
| Iizuka Hp., Fukuoka, Resp. Med. | Ebi, Noriyuki | Japan | NA | Iizuka, Fukuoka |
| Okinawa Pref Nanbu Med Ct&Children Med Ct, Okinawa, Resp Med | Azuma, Masato | Japan | NA | Shimajiri-gun, Okinawa |
| Chibana Clinic, Okinawa, Resp. Med. | Ishimine, Tomohiko | Japan | NA | Okinawa, Okinawa |
| Naha City Hp., Okinawa, I.M. | Kyan, Yukio | Japan | NA | Naha, Okinawa |
| Tomishiro Ctr Hp, Okinawa, Resp. Med. | Matsumoto, Tsuyoshi | Japan | NA | Tomigusuku, Okinawa |
| Nanbu Tokushukai Hp., Okinawa, Dep. of Thoracic Surgery | Shimoji, Mitsuyoshi | Japan | NA | Shimajiri-gun, Okinawa |
| National Ctr for Global Health and Med., Tokyo, Resp. Med. | Izumi, Shinyu | Japan | NA | Shinjuku-ku, Tokyo |
| Flattum Legesenter, Honefoss | Gronert, Jorn Ossum | Norway | NA | Honefoss |
| Dr. Thomas Karlsson, Klofta | Karlsson, Thomas | Norway | NA | Klofta |
| Oslo Barne- og Lungelegesenter, Oslo | Myhr, Leiv | Norway | NA | Oslo |
| Norsk Helseklinikk AS, Lierskogen | Solnor, Leidulv | Norway | NA | Lierskogen |
| Medi 3 Innlandet AS, avd Elverum | Elle, Sigbjorn | Norway | NA | Elverum |
| Ski Spesialistsenter, Ski | Borge, Lars | Norway | NA | Ski |
| Svelvik Legesenter, Svelvik | Tomala, Tadeusz | Norway | NA | Svelvik |
| Hospital Nossa Senhora da Conceicao | Mattos, Waldo Luis Leite Dias | Brazil | RS | Porto Alegre |
| Hospital Sao Lucas da PUCRS | Fritscher, Carlos Cezar | Brazil | RS | Porto Alegre |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Rubin, Adalberto Sperb | Brazil | RS | Porto Alegre |
| Associacao Hospitalar Moinhos de Vento | Do Valle, Enio Luiz Tschiedel | Brazil | RS | Porto Alegre |
| Lar Escola Sao Francisco | Jardim, José Roberto Brito | Brazil | SP | Sao Paulo |
| Centro de Pesquisa Clinica - CPCLIN | Lastebasse, Flavio Gnecco | Brazil | BR | Sao Paulo |
| Hospital de Clínicas de Porto Alegre | Knorst, Marli | Brazil | RS | Porto Alegre |
| Hospital Universitario da Univers. Federal de Santa Catarina | Pizzichini, Emilio | Brazil | SC | Florianopolis |
| Hospital das Clínicas de Sao Paulo - INCOR | Cukier, Alberto | Brazil | SP | Sao Paulo |
| Hospital Sao Vicente de Paulo | Mello, Danuza Avila | Brazil | RS | Passo Fundo |
| Hospital das Clinicas de Botucatu | Minamoto, Suzana Erico Tanni | Brazil | SP | Botucatu |
| Fundacion Clinica Shaio | Severiche, Diego | Columbia | Bogota | Bogota DC |
| Centro Especializado en Enfermedades Pulmonares | Matiz, Carlos | Columbia | Bogota | Bogota DC |
| Fundación Oftalmologica de Santander | Bolivar, Fabio | Columbia | Santander | Floridablanca |
| Fundación Valle del Lili | Fernandez, Liliana | Columbia | Valle Cauc | Cali |
| Hospital Santa Clara E.S.E. | Serrano, Francisco | Columbia | Bogota | Bogota DC |
| Fundacao Neumologica Colombiana | Conde, Rafael | Columbia | NA | Bogota |
| National Taiwan University Hospital | Kuo, Ping-Hung | 中国 | NA | Taipei |
| Far Eastern Memorial Hospital | Cheng, Shih-Lung | 中国 | NA | New Taipei City |
| Chang Gung Memorial Hospital | Yang, Cheng-Ta | 中国 | NA | Taoyuan County |
| China Medical University Hospital | Hang, Liang-Wen | 中国 | NA | Taichung |
| National Cheng Kung University Hospital | Hsiue, Tzuen-Ren | 中国 | NA | Tainan |
| Chang Gung Memorial Hospital Kaohsiung | Wang, Chin-Chou | 中国 | NA | Kaohsiung City |
| E-Da Hospital | Wei, Yu-Feng | 中国 | NA | Kaohsiung |
| KH der Elisabethinen Linz, Abt. Pneumologie | Bolitschek, Josef | Austria | NA | Linz |
| Univ.-Klinik für Innere Medizin Innsbruck | Kahler, Christian Matthias | Austria | NA | Innsbruck |
| LKH Salzburg - Universitatsklinik für Pneumologie | Studnicka, Michael | Austria | NA | Salzburg |
| Ordination Dr. Flicker c/o Arbeitsmed.Zentrum d.Voest Alpine | Flicker, Martin | Austria | NA | Leoben |
| Ordination Dr. Wolfgang Pohl, 2230 Ganserndorf | Pohl, Wolfgang | Austria | NA | Ganserndorf |
| Ordination Dr. Robert Voves, 8330 Feldbach | Voves, Robert | Austria | NA | Feldbach |
| University of Debrecen | Szilasi, Maria | Hungary | NA | Debrecen |
| Institute of Chest Diseases of Csongrad, Szeged | Balint, Beatrix | Hungary | NA | Szeged |
| Erzsebet Hospital Sopron | Bartfai, Zoltan | Hungary | NA | Sopron |
| Tormay Karoly Health Center, Godollo | Mucsi, Janos | Hungary | NA | Godollo |
| United Institutes of Public Health, Pecs | Varga, Agnes | Hungary | NA | Pecs |
| Hospital for Pulmonary Diseases, Zagreb | Glad, Ljerka | Croatia | NA | Zagreb |
| General Hosp. Zadar, Dept. of Internal Medicine-Pulmonology | Sinovcic-Kolanovic, Suzana | Croatia | NA | Zadar |
| General Hosp. | Stjepanovic, Gordana | Croatia | NA | Petrinja |
| Clincal Hospital Centre Rijeka | Matanic, Dubravka | Croatia | NA | Rijeka |
| Emergency Clinical Hospital n. a. N. V. Soloviev, Yaroslavl | Palyutin, Shamil | Russia | NA | Yaroslavl |
| State Medical University | Trofimov, Vasiliy | Russia | NA | St. Petersburg |
| Medical Research Institute LLC, St. Petersburg | Stitsenko, Irina A. | Russia | NA | St. Petersburg |
| GUZ City Clinical Hospital no. 7, Moscow | Sidorenko, Irina | Russia | NA | Moscow |
| City Clinical Hospital no. 12, Moscow | Karabinenko, Alexandr | Russia | NA | Moscow |
| Quantum Medical Center, Bucharest | Tudorache, Mirela | Romania | NA | Bucharest |
| Centrul Medical SANA, Bucuresti | Popescu, Elena | Romania | NA | Bucuresti |
| Spitalul Clinic de Pneumoftizologie Leon Daniello, Cluj | Todea, Doina A | Romania | NA | Cluj |
| Emergency Clin. County Hosp. Pneumology Dept. | Nini, Georghe | Romania | NA | Arad |
| Dr. Dana Olar Praxis Ltd., Pneumology | Olar, Dana | Romania | NA | Arad |
| St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov | Lescisinova, Helena | Slovakia | NA | Bardejov |
| Pulmo-Medik s.r.o. Outpatient Clinic of Pneumology | KUBIKOVA, Yveta | Slovakia | NA | Bojnice |
| Plucna Ambulancia Hrebenar s.r.o. | Hrebenar, Slavomir | Slovakia | NA | Spisska Nova Ves |
| Medipobcom s.r.o. | Pobehova, Maria | Slovakia | NA | Kosice |
| Faculty Hospital Zilina, Outpatient Clinic of Pneumology | Paluchova, Maria | Slovakia | NA | Zilina |
| Imunoalergologia Dr. Dzurilla s.r.o. | Dzurilla, Martin | Slovakia | NA | Nitra |
| Clinic for Pulmonary Diseases and TBC Knez Selo | Stankovic, Ivana | Serbia | NA | Nis |
| Centre for Pulmonary Diseases Kragujevac | Lazic, Zorica | Serbia | NA | Kragujevac |
| Institute for Pulmonary Diseases and TBC,CCS | Milikic, Marija Mitic | Serbia | NA | Belgrade |
| Institute for Pulmonary Diseases and TBC,CCS | Milenkovic, Branislava | Serbia | NA | Belgrade |
| Clinical Hospital Center | Vukcevic, Miodrag | Serbia | NA | Belgrade |
| Skanes universitetssjukhus, Lund | Bjermer, Leif | Sweden | NA | Lund |
| Me3 plus clinical trials, Goteborg | Curiac, Dan | Sweden | NA | Goteborg |
| Bjorknas Vardcentral, Boden | Lindberg, Anne | Sweden | NA | Boden |
| Karolinska Universitetssjukhuset, Solna | Skold, Magnus | Sweden | NA | Stockholm |
| Nasets lakargrupp, Hollviken | Romberg, Kerstin | Sweden | NA | Hollviken |
| Sjukhuset, Harnosand | Kempe, Anders | Sweden | NA | Harnosand |
| Vardcentralen Silentzvagen, Uddevalla | Polhem, Bo | Sweden | NA | Uddevalla |
| Ege Universitesi Tip Fakultesi Gogüs Hastaliklari ABD | Sayiner, Abdullah | Turkey | NA | Izmir |
| Dr. Suat Seren Gogus Has ve Gogus Cerrahisi Egit ve Aras Has | Guclu, Salih Zeki | Turkey | NA | Izmir |
| Pamukkale Universitesi Tip Fakultesi Hastanesi | Evyapan, Fatma | Turkey | NA | Denizli |
| Bezmi Alem Vakif Universitesi Tip Fakultesi Hastanesi | Kart, Levent | Turkey | NA | Istanbul |
| Ankara Universitesi Tip Fakultesi Cebeci Has.Gogus Has.ABD | Yildiz, Oznur | Turkey | NA | Ankara |
| Wythenshawe Hospital, The Medicines Evaluation Unit | Singh, Dave | Great Britain | NA | Manchester |
| Waterloo Medical Centre, Blackpool | Calvert, John | Great Britain | NA | Blackpool |
| Bristol Royal Infirmary, Respiratory Dept. | Jarad, Dr Nabil | Great Britain | NA | Bristol |
| St Chad's Surgery, Midsomer Norton | Jones, Nick | Great Britain | Avon | Midsomer Norton |
| Layton Medical Centre, Blackpool | Kerrane, Jerome | Great Britain | NA | Blackpool |
| St Peter's Hospital, Dept of Respiratory Medicine | Nordstrom, Monica | Great Britain | Surrey | Chertsey |
| Belle Vue Surgery, Fleetwood | Ramesh, Dr Cobarsanellore | Great Britain | NA | Fleetwood |
| St. Vincent's University Hospital, Respiratory Dept. | Butler, Marcus W | Ireland | NA | Dublin |
| The Adelaide & Meath Hospital, Dept of Respiratory Medicine | Lane, Stephen | Ireland | NA | Dublin |
| Mid-Western Regional Hospital, Respiratory Medicine | O'Brien, Aidan | Ireland | NA | County Limerick |
| UCT Lung Institute: Respiratory | Bateman, Eric | South Africa | NA | Cape Town |
| Tiervlei Trial Centre | Joubert, James Rattray | South Africa | NA | Bellville |
| Gatesville Medical Centre 308 | Abdullah, Ismail | South Africa | NA | Cape Town |
| H08 Panorama Medi-Clinic | Richter, Daphne | South Africa | NA | Cape Town |
| Pretoria East Hospital | Ras, Gerhard | South Africa | NA | Pretoria |
| Henry D. Covelli, MD | Covelli, Henry | America | ID | Couer d'Alene |
| Lovelace Scientific Resources | Dorf, Jeffrey | America | NM | Albuquerque |
| Rowan Research Inc | Lochner, Jerrel | America | WA | Spokane |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 复旦大学附属中山医院伦理委员会 | 同意 | 2012-03-22 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 275 人；
国际: 2500 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 292 人 ；
国际: 2519 人；
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：2012-03-29；
国际：2010-09-15；
试验终止日期
国内：2013-12-09；
国际：2013-12-09；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
