A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Treatment), Ambroxol Hydrochloride 30 mg Twice Daily (Active Control Treatment) and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Zambon SpA
- 入组人数
- 333
- 试验地点
- 31
- 主要终点
- Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both rater and patient will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult (≥18 years old) hospitalized patients with respiratory tract diseases and abnormal mucus secretions such as: acute bronchitis, chronic bronchitis and exacerbations, emphysema, mucoviscidosis and bronchiectasis.
- •Chinese ethnicity and/or Chinese
- •Signed the informed consent form before any study-related procedure
- •Sputum viscosity score ≥ 2 at randomization visit
- •Expectoration difficulty score ≥ 2 at randomization visit
- •Willingness and ability to comply with study procedures
排除标准
- •Intolerance or contra-indication to treatment with NAC or ambroxol or allergy to any component of the study treatments
- •(For female patients) ongoing pregnancy or lactation, or childbearing potential but unwillingness to adopt abstinence or contraception measures during the study
- •Intake of an investigational drug within 1 month before the screening visit
- •Use of expectorants or drugs with expectorant effect within 2 days before randomization visit
- •Diagnosis of active tuberculosis, lung cancer, pulmonary fibrosis, acute pulmonary thromboembolism or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the patient or affect the interpretation of the results
- •Medical history of and/or illness (including laboratory abnormality) and/or treatment that in the investigator's opinion may interfere with the patient's safety, compliance, or study evaluations
- •Serum alanine aminotransferase and/or aspartate transaminase more than 3 times above the upper limit of normal at screening visit
- •Serum creatinine more than 3 times above the upper limit of normal at screening visit
- •Addiction to alcohol or drugs
- •Mental illness, or other reasons for non-cooperation in the investigator's opinion
研究组 & 干预措施
Active test treatment-NAC
NAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
干预措施: N-acetylcysteine (NAC) 600 mg (Drug)
Active control treatment-Ambroxol hydrochloride
Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
干预措施: Ambroxol hydrochloride 30 mg (Drug)
Placebo
Placebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
时间窗: From baseline upto Day 7
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales \[0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)\] with 0 = best and 3= worst.
Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo
时间窗: From Baseline upto Day 7
The superiority of slow intravenous infusion of NAC 600 mg twice daily to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales \[0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty\] with 0 = best and 3 = worst.
次要结局
- Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo(From Baseline to Day 3)
- Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride(From baseline upto Day 7)
- Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo(From Baseline to Day 3)
- Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride(From Baseline upto Day 7)
- Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo(From Baseline upto Day 3 and Day 7)
- Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo(From Baseline upto Day 3 and Day 7)