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NCT Number: NCT03843541

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

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.

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Key information

Conditions

Respiratory Tract Diseases Abnormal Mucus Secretions Bronchial Diseases Bronchitis Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cough Cystic Fibrosis Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Lung Diseases, Obstructive Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wuxi Peoples' Hospital affiliated to Nanjing Medical University, Wuxi, No. 299, Qing Yang Rd., Wuxi City, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine (NAC) 600 mg

Drug

NAC will be administered twice a day, morning and evening, during treatment period.

Other names: Fluimucil®

Ambroxol hydrochloride 30 mg

Drug

Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.

Other names: Mucosolvan®, Fluibron®

Placebo

Other

Placebo will be administered twice a day, morning and evening, during treatment period.

Primary outcomes

  1. Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo

    Time frame: 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.

  2. Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo

    Time frame: From Baseline to Day 3

    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.

  2. Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo

    Time frame: From Baseline to Day 3

    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.

  3. Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  4. Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  5. Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  6. Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride

    Time frame: From baseline upto Day 7

    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.

  7. Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride

    Time frame: From Baseline upto Day 7

    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

  8. Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  9. Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  10. Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  11. Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

  12. Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo

    Time frame: From Baseline upto Day 3 and Day 7

    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.

Other outcomes

  1. Number of Participants With Adverse Events

    Time frame: From screening to follow-up after the last administration of the investigational medicinal product (IMP) [assessed up to 19 months]

    The safety and tolerability of intravenous NAC 600 mg twice daily was demonstrated.

Sponsors and collaborators

Lead sponsor

Zambon SpA

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2019
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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