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
NCT ID: NCT03843541
Last Updated: 2025-09-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2019-06-25
2021-02-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
N-acetylcysteine (NAC) for the Treatment of Acute Exacerbation of COPD
NCT05706402
Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients
NCT05663905
The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01136239
A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
NCT06958861
A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion
NCT06820749
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active test treatment-NAC
NAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
N-acetylcysteine (NAC) 600 mg
NAC will be administered twice a day, morning and evening, during treatment period.
Active control treatment-Ambroxol hydrochloride
Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Ambroxol hydrochloride 30 mg
Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
Placebo
Placebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
placebo
Placebo will be administered twice a day, morning and evening, during treatment period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
N-acetylcysteine (NAC) 600 mg
NAC will be administered twice a day, morning and evening, during treatment period.
Ambroxol hydrochloride 30 mg
Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
placebo
Placebo will be administered twice a day, morning and evening, during treatment period.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Chinese ethnicity and/or Chinese
3. Signed the informed consent form before any study-related procedure
4. Sputum viscosity score ≥ 2 at randomization visit
5. Expectoration difficulty score ≥ 2 at randomization visit
6. Willingness and ability to comply with study procedures
Exclusion Criteria
2. (For female patients) ongoing pregnancy or lactation, or childbearing potential but unwillingness to adopt abstinence or contraception measures during the study
3. Intake of an investigational drug within 1 month before the screening visit
4. Use of expectorants or drugs with expectorant effect within 2 days before randomization visit
5. 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
6. 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
7. Serum alanine aminotransferase and/or aspartate transaminase more than 3 times above the upper limit of normal at screening visit
8. Serum creatinine more than 3 times above the upper limit of normal at screening visit
9. Addiction to alcohol or drugs
10. Mental illness, or other reasons for non-cooperation in the investigator's opinion
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zambon SpA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wuxi Peoples' Hospital affiliated to Nanjing Medical University
Wuxi, No. 299, Qing Yang Rd., Wuxi City, Jiangsu, China
Inner Mongolia Baogang Hospital
Baotou, , China
Beijing Hospital
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking University Shougang Hospital
Beijing, , China
Jilin Province People's Hospital
Changchun, , China
The First Bethune Hospital of Jilin University
Changchun, , China
Chengdu Fifth People's Hospital
Chengdu, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Deyang People's Hospital
Deyang, , China
Inner Mongolia People's Hospital
Hohhot, , China
Jinhua city central hospital/Jinhua hospital ,School of Medicine,Zhejiang UNIVERSITY
Jinhua, , China
Nanchang University-The Second Affiliated Hospital
Nanchang, , China
Nanjing First Hospital
Nanjing, , China
Zhongda Hospital, Southeast University - Pulmonology
Nanjing, , China
Jiangxi Pingxiang People's Hospital
Pingxiang, , China
Qingdao Municipal Hospital
Qingdao, , China
Minhang District Central Hospital
Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Suining Central Hospital
Suining, , China
First Hospital of Shanxi Medical University
Taiyuan, , China
The First Hospital of Shanxi Medical University
Taiyuan, , China
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
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Z7244L01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.