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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
Phase of Trial: Phase III
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-4
- Sponsors Aradigm Corporation
- 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 According to a Aradigm media release, based on the meetings with FDA in December 2016 and March 2017, the statistical analysis of the results was changed from the pre-specified plan to stratification based on sex and the frequency of pulmonary exacerbations in the prior year, as the stratum for current smokers contained a small number of subjects.
- 27 Jul 2017 Top-line results using the new stratification, published in the Aradigm media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History