Phase 3 N=333 Randomized Double-blind Treatment

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

Respiratory Tract Diseases · Abnormal Mucus Secretions

Bottom Line

View on ClinicalTrials.gov: NCT03843541 ↗

Enrolled (actual)

333

Serious AEs

4.3%

Results posted

Jan 2023

Primary outcome: Primary: Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo — -1.2; -1.0 Score — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: N-acetylcysteine (NAC) 600 mg (Drug); Ambroxol hydrochloride 30 mg (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zambon SpA
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo	-1.2; -1.0	<0.001 sig
PRIMARY Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo	-1.4; -1.1	0.002 sig
SECONDARY Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo	-0.6; -0.6	0.239
SECONDARY Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo	-0.8; -0.7	0.037 sig
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo	-0.5; -0.5; -0.8; -0.8	0.093
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo	-0.4; -0.5; -0.8; -0.6	0.022 sig
SECONDARY Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo	-1.601; -4.144; -9.405; -7.391	0.022 sig
SECONDARY Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride	-1.2; -1.2	0.002 sig
SECONDARY Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride	-1.4; -1.3	<0.001 sig
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo	-0.6; -0.6; -1.2; -1.0	0.356
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo	-0.7; -0.7; -1.3; -1.1	0.380
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo	-0.5; -0.5; -0.9; -0.8	0.366
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo	-0.4; -0.5; -0.7; -0.6	0.052
SECONDARY Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo	-4.53; -4.14; -9.73; -7.39	0.309

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03843541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.