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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

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研究单位： [1]Zambon SpA [2]Inner Mongolia Baogang Hospital [3]Beijing Hospital [4]Tongji Hospital,Tongji Medical College of Huazhong University Science and Technology Wuhan,China Wuxi Peoples' Hospital affiliated to Nanjing Medical University Wuxi,China Yangzhou First People's Hospital Yangzhou,China General Hospital of Ningxia Medical University Yinchuan,China Affiliated Hospital of Guangdong Medical University - Respiration Zhanjiang,China The First People's Hospital of Zigong Zigong,China

关键词： N-acetylcysteine (NAC) ambroxol hydrochloride bronchitis cystic fibrosis fibrosis bronchiectasis increased sputum viscosity cough Chronic Obstructive Pulmonary Disease (COPD)

研究目的：

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.