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: 27 Jul 2017
At a glance
- Drugs Ciprofloxacin (Primary)
- Indications Bronchiectasis; Pseudomonal infections; Respiratory tract infections
- Focus Registrational; Therapeutic Use
- Acronyms ORBIT-2
- 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.
- 21 Sep 2011 Additional results will be presented at the European Respiratory Society Annual Congress, according to an Aradigm Corporation media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History