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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

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At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Bronchiectasis; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ORBIT-3
  • Sponsors Aradigm Corporation

Most Recent Events

  • 18 Jun 2020 Results assessing changes in respiratory symptoms during 48 weeks treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis published in the European Respiratory Journal
  • 30 Oct 2019 According to an Aradigm Corporation media release, the company has withdrawn its Marketing Authorization Application (MAA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections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.
  • 21 Feb 2019 According to an Aradigm media release, in a Type B meeting with the FDA, the company presented the results of the Third Party Evaluation (TPE) completed in December 2018 that addressed the clinical issue raised by the FDA in the complete response letter (CRL) received in January 2018. Following FDA guidance provided in a Type C meeting, a new Human Factor study and work to address the product quality deficiencies are currently nearing completion.

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