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.
Phase of Trial: Phase II
Latest Information Update: 25 Sep 2017
At a glance
- Drugs Ciprofloxacin (Primary)
- Indications Bronchiectasis; Pseudomonal infections; Respiratory tract infections
- Focus Registrational; Therapeutic Use
- Acronyms ORBIT-2
- 25 Sep 2017 According to an Aradigm Corporation media release, the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa). The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Linhaliq NDA is January 26, 2018.
- 27 Jul 2017 Based on the results of ORBIT-2, ORBIT-3, ORBIT-4, studies Aradigm submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).
- 07 Oct 2016 Results published in the Aradigm corporation Media Release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History