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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2025

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At a glance

  • Drugs Acetylcysteine (Primary) ; Ambroxol
  • Indications Acute bronchitis; Bronchiectasis; Chronic bronchitis; Cystic fibrosis; Emphysema; Respiratory tract disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Zambon SpA

Most Recent Events

  • 24 Jun 2025 According to Zambon Biotech SA media release, company announced the approval by Chinese regulatory authorities and the launch on the Chinese market of the intravenous (IV) formulation of Fluimucil (N-acetylcysteine). The approval is based on locally conducted Phase 1 and a Phase 3 clinical trial that confirmed the drug's safety, tolerability, and efficacy profile.
  • 22 Feb 2021 Status changed from recruiting to completed.
  • 20 May 2020 Planned End Date changed from 30 Apr 2020 to 24 Apr 2021.

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