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An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Mixture Formulation Consisting of Liposomal and Free Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non-Cystic Fibrosis Bronchiectasis with Chronic Lung Infections.

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Trial Profile

An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Mixture Formulation Consisting of Liposomal and Free Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non-Cystic Fibrosis Bronchiectasis with Chronic Lung Infections.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2019

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At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Bronchiectasis; Pseudomonal infections; Respiratory tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ORBIT-2
  • Sponsors Aradigm Corporation

    • Most Recent Events

    • 30 Oct 2019 According to an Aradigm Corporation media release, the company has withdrawn its Marketing Authorization Application (MAA) in Europe, for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa. The decision came after the company learned that the CHMP was likely to formally adopt a negative opinion in its evaluation of the application.
    • 09 Mar 2018 Based on the results of ORBIT-2, ORBIT-3, ORBIT-4, Aradigm is submitting a mixed MAA for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis to European Medicines Agency (EMA).
    • 29 Jan 2018 According to an Aradigm Corporation media release, company has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with P. aeruginosa.
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