Back to resultsA 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
Primary Purpose
Respiratory Tract Diseases, Abnormal Mucus Secretions
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
N-acetylcysteine (NAC) 600 mg
Ambroxol hydrochloride 30 mg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Diseases focused on measuring N-acetylcysteine (NAC), ambroxol hydrochloride, bronchitis, cystic fibrosis, fibrosis bronchiectasis, increased sputum viscosity, cough, Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Wuxi Peoples' Hospital affiliated to Nanjing Medical University
- Inner Mongolia Baogang Hospital
- Beijing Hospital
- Beijing Tongren Hospital
- China-Japan Friendship Hospital
- Peking University Shougang Hospital
- Jilin Province People's Hospital
- The First Bethune Hospital of Jilin University
- Chengdu Fifth People's Hospital
- West China Hospital, Sichuan University
- The First Affiliated Hospital of Chongqing Medical University
- Deyang People's Hospital
- Inner Mongolia People's Hospital
- Jinhua city central hospital/Jinhua hospital ,School of Medicine,Zhejiang UNIVERSITY
- Nanchang University-The Second Affiliated Hospital
- Nanjing First Hospital
- Zhongda Hospital, Southeast University - Pulmonology
- Jiangxi Pingxiang People's Hospital
- Qingdao Municipal Hospital
- Minhang District Central Hospital
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- Shanghai General Hospital
- Shanghai Pulmonary Hospital
- Suining Central Hospital
- First Hospital of Shanxi Medical University
- The First Hospital of Shanxi Medical University
- Tongji Hospital, Tongji Medical College of Huazhong University Science and Technology
- Wuxi Peoples' Hospital affiliated to Nanjing Medical University
- Yangzhou First People's Hospital
- General Hospital of Ningxia Medical University
- Affiliated Hospital of Guangdong Medical University - Respiration
- The First People's Hospital of Zigong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Active test treatment-NAC
Active control treatment-Ambroxol hydrochloride
Placebo
Arm Description
NAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Placebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Outcomes
Primary Outcome Measures
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
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
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.
Secondary Outcome Measures
Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo
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 3 in Mean Expectoration Difficulty Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC 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.
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum color score was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst.
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst.
Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h.
Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean 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 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean 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
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo
The superiority of the slow intravenous infusion ambroxol hydrochloride 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 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo
The superiority of the slow intravenous infusion of ambroxol hydrochloride 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.
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in sputum color was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst.
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst.
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in mean sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03843541
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
January 23, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zambon SpA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases, Abnormal Mucus Secretions
Keywords
N-acetylcysteine (NAC), ambroxol hydrochloride, bronchitis, cystic fibrosis, fibrosis bronchiectasis, increased sputum viscosity, cough, Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
There will be 3 treatment groups of NAC, ambroxol and placebo. A total of 333 patients will be randomized to NAC or ambroxol or placebo in a 1:1:1 ratio. Approximately 111 patients will be randomized in each treatment group.
Masking
ParticipantOutcomes Assessor
Masking Description
Both rater and patient will be blinded.
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active test treatment-NAC
Arm Type
Experimental
Arm Description
NAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Arm Title
Active control treatment-Ambroxol hydrochloride
Arm Type
Active Comparator
Arm Description
Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine (NAC) 600 mg
Other Intervention Name(s)
Fluimucil®
Intervention Description
NAC will be administered twice a day, morning and evening, during treatment period.
Intervention Type
Drug
Intervention Name(s)
Ambroxol hydrochloride 30 mg
Other Intervention Name(s)
Mucosolvan®, Fluibron®
Intervention Description
Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo will be administered twice a day, morning and evening, during treatment period.
Primary Outcome Measure Information:
Title
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
Description
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.
Time Frame
From baseline upto Day 7
Title
Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo
Description
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.
Time Frame
From Baseline upto Day 7
Secondary Outcome Measure Information:
Title
Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo
Description
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.
Time Frame
From Baseline to Day 3
Title
Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo
Description
The superiority of slow intravenous infusion of NAC 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.
Time Frame
From Baseline to Day 3
Title
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo
Description
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum color score was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo
Description
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo
Description
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride
Description
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean 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.
Time Frame
From baseline upto Day 7
Title
Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride
Description
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean 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
Time Frame
From Baseline upto Day 7
Title
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo
Description
The superiority of the slow intravenous infusion ambroxol hydrochloride 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.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo
Description
The superiority of the slow intravenous infusion of ambroxol hydrochloride 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.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo
Description
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in sputum color was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo
Description
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst.
Time Frame
From Baseline upto Day 3 and Day 7
Title
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo
Description
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in mean sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h.
Time Frame
From Baseline upto Day 3 and Day 7
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events
Description
The safety and tolerability of intravenous NAC 600 mg twice daily was demonstrated.
Time Frame
From screening to follow-up after the last administration of the investigational medicinal product (IMP) [assessed up to 19 months]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Wuxi Peoples' Hospital affiliated to Nanjing Medical University
City
Wuxi
State/Province
No. 299, Qing Yang Rd., Wuxi City, Jiangsu
Country
China
Facility Name
Inner Mongolia Baogang Hospital
City
Baotou
Country
China
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
Country
China
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Chengdu Fifth People's Hospital
City
Chengdu
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Deyang People's Hospital
City
Deyang
Country
China
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
Country
China
Facility Name
Jinhua city central hospital/Jinhua hospital ,School of Medicine,Zhejiang UNIVERSITY
City
Jinhua
Country
China
Facility Name
Nanchang University-The Second Affiliated Hospital
City
Nanchang
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
Country
China
Facility Name
Zhongda Hospital, Southeast University - Pulmonology
City
Nanjing
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
Country
China
Facility Name
Minhang District Central Hospital
City
Shanghai
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Facility Name
Suining Central Hospital
City
SuiNing
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University Science and Technology
City
Wuhan
Country
China
Facility Name
Wuxi Peoples' Hospital affiliated to Nanjing Medical University
City
Wuxi
Country
China
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University - Respiration
City
Zhanjiang
Country
China
Facility Name
The First People's Hospital of Zigong
City
Zigong
Country
China
12. IPD Sharing Statement
Learn more about this trial
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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