A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
研究单位：[1]Zambon SpA[2]Wuxi Peoples' Hospital affiliated to Nanjing Medical University,Wuxi,No. 299, Qing Yang Rd., Wuxi City, Jiangsu,China[3]Inner Mongolia Baogang Hospital,Baotou,China[4]Beijing Hospital,Beijing,China[5]Beijing Tongren Hospital,Beijing,China[6]China-Japan Friendship Hospital,Beijing,China[7]Peking University Shougang Hospital,Beijing,China[8]Jilin Province People's Hospital,Changchun,China[9]The First Bethune Hospital of Jilin University,Changchun,China[10]Chengdu Fifth People's Hospital,Chengdu,China[11]West China Hospital, Sichuan University,Chengdu,China[12]The First Affiliated Hospital of Chongqing Medical University,Chongqing,China[13]Deyang People's Hospital,Deyang,China[14]Inner Mongolia People's Hospital,Hohhot,China[15]Jinhua city central hospital/Jinhua hospital ,School of Medicine,Zhejiang UNIVERSITY,Jinhua,China[16]Nanchang University-The Second Affiliated Hospital,Nanchang,China[17]Nanjing First Hospital,Nanjing,China[18]Zhongda Hospital, Southeast University - Pulmonology,Nanjing,China[19]Jiangxi Pingxiang People's Hospital,Pingxiang,China[20]Qingdao Municipal Hospital,Qingdao,China[21]Minhang District Central Hospital,Shanghai,China[22]Ruijin Hospital, Shanghai Jiao Tong University School of Medicine,Shanghai,China[23]Shanghai General Hospital,Shanghai,China[24]Shanghai Pulmonary Hospital,Shanghai,China[25]Suining Central Hospital,SuiNing,China[26]First Hospital of Shanxi Medical University,Taiyuan,China[27]The First Hospital of Shanxi Medical University,Taiyuan,China[28]Tongji Hospital, Tongji Medical College of Huazhong University Science and Technology,Wuhan,China[29]Wuxi Peoples' Hospital affiliated to Nanjing Medical University,Wuxi,China[30]Yangzhou First People's Hospital,Yangzhou,China[31]General Hospital of Ningxia Medical University,Yinchuan,China[32]Affiliated Hospital of Guangdong Medical University - Respiration,Zhanjiang,China[33]The First People's Hospital of Zigong,Zigong,China
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial. Patients will be randomized to N-acetylcysteine (NAC) or ambroxol or placebo in a 1:1:1 ratio. A total of approximately 333 patients in China will be randomized. The total study duration will be approximately 8 months including the enrolment period of approximately 7 months and the patient participation duration of 1 month or 4 weeks. Each patient will undergo a screening period of up to 1 week, a 1-week treatment period and a 2-week follow-up period. This study will be conducted in approximately 15-25 sites in China.
