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
Condition: Respiratory Tract Diseases; Abnormal Mucus Secretions
MeSH terms: Respiratory Tract Diseases
Intervention: N-acetylcysteine (NAC) 600 mg; Ambroxol hydrochloride 30 mg; placebo
Intervention description: NAC will be administered twice a day, morning and evening, during treatment period.; Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.; Placebo will be administered twice a day, morning and evening, during treatment period.
Intervention MeSH terms: Acetylcysteine; Ambroxol; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Masking description: Both rater and patient will be blinded.
Enrollment: 333.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: N-acetylcysteine (NAC); ambroxol hydrochloride; bronchitis; cystic fibrosis; fibrosis bronchiectasis; increased sputum viscosity; cough; Chronic Obstructive Pulmonary Disease (COPD)

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:

          1. 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.

          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:

          1. Intolerance or contra-indication to treatment with NAC or ambroxol or allergy to any
             component of the study treatments

          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