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: 27 Jul 2017
At a glance
- Drugs Ciprofloxacin (Primary)
- Indications Bronchiectasis; Pseudomonal infections; Respiratory tract infections
- Focus Registrational; Therapeutic Use
- Acronyms ORBIT-4
- Sponsors Aradigm Corporation
- 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.
- 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).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History