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

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

Completed
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-3
  • Sponsors Aradigm Corporation
  • Most Recent Events

    • 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 are 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).
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