Status:
COMPLETED
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
Lead Sponsor:
Zambon SpA
Conditions:
Respiratory Tract Diseases
Abnormal Mucus Secretions
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ambr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT03843541
Start Date
June 25 2019
End Date
February 5 2021
Last Update
September 5 2025
Active Locations (32)
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1
Wuxi Peoples' Hospital affiliated to Nanjing Medical University
Wuxi, No. 299, Qing Yang Rd., Wuxi City, Jiangsu, China
2
Inner Mongolia Baogang Hospital
Baotou, China
3
Beijing Hospital
Beijing, China
4
Beijing Tongren Hospital
Beijing, China