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A Double-Blind Randomized Placebo-Controlled Phase 3 Trial of Tobramycin Inhalation Solution in Adults With Bronchiectasis With Pseudomonas aeruginosa Infection
Institution:1. State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China;2. Department of Thoracic Surgery, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China;3. Department of Respiratory and Critical Care Medicine, Institute of Respiratory Medicine, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China;4. Department of Pulmonary and Critical Care Medicine, Second Xiangya Hospital, Central South University, Changsha, Hunan, China;5. Subei People’s Hospital, Suzhou, Jiangsu, China;6. Zhongshan Hospital, Fudan University, Shanghai, China;7. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;8. Affiliated West China Hospital of Sichuan University, Chengdu, Sichuan, China;9. Tsingtao Municipal Hospital, Qingdao, Shandong, China;10. Department of Respiratory and Critical Care Medicine, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China;11. Henan Provincial People’s Hospital, Zhengzhou, Henan, China;12. Xinxiang First People’s Hospital, Xinxiang, Henan, China;13. Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China;14. Affiliated Huaihe Hospital of Henan University, Huaihe, Henan, China;15. Hainan General Hospital, Haikou, Hainan, China;p. Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China;q. Qingyuan People’s Hospital, Qingyuan, Guangdong, China;r. Second Affiliated Hospital of Anhui Medical University, Anhui, China;s. State Key Laboratory of Organ Failure Research, Department of Biostatistics, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University;t. Affiliated Ruijin Hospital, School of Medicine, Shanghai Jiaotong University;1. Departments of Internal Medicine, Hamilton, ON, Canada;2. Health Research Methods Evidence and Impact, Hamilton, ON, Canada;3. Anesthesiology, McMaster University, Hamilton, ON, Canada;1. Monash University, Melbourne, VIC, Australia;2. University of Melbourne, Melbourne, VIC, Australia;3. University of California San Diego, San Diego, CA;1. Division of Thoracic Surgery Toronto General Hospital, Toronto, ON, Canada;2. Latner Thoracic Research Laboratories, Toronto, ON, Canada;3. Ajmera Transplant Centre University Health Network, Toronto, ON, Canada
Abstract:
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  • Keywords:bacterial density  bronchiectasis  quality of life  tobramycin inhalation solution  BHQ"}  {"#name":"keyword"  "$":{"id":"kwrd0040"}  "$$":[{"#name":"text"  "_":"Bronchiectasis Health Questionnaire  BSI"}  {"#name":"keyword"  "$":{"id":"kwrd0050"}  "$$":[{"#name":"text"  "_":"Bronchiectasis Severity Index  LSM"}  {"#name":"keyword"  "$":{"id":"kwrd0060"}  "$$":[{"#name":"text"  "_":"least-squares mean  MCID"}  {"#name":"keyword"  "$":{"id":"kwrd0070"}  "$$":[{"#name":"text"  "_":"minimal clinically important difference  mITT"}  {"#name":"keyword"  "$":{"id":"kwrd0080"}  "$$":[{"#name":"text"  "_":"modified intention-to-treat  PP"}  {"#name":"keyword"  "$":{"id":"kwrd0090"}  "$$":[{"#name":"text"  "_":"per protocol  QoL-B-RSS"}  {"#name":"keyword"  "$":{"id":"kwrd0100"}  "$$":[{"#name":"text"  "_":"Quality-of-Life Bronchiectasis Respiratory Symptoms score  TIS"}  {"#name":"keyword"  "$":{"id":"kwrd0110"}  "$$":[{"#name":"text"  "_":"tobramycin inhalation solution
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