Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Bronchiectasis; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ORBIT-4
  • Sponsors Aradigm Corporation
  • Most Recent Events

    • 18 Jun 2020 Results assessing changes in respiratory symptoms during 48 weeks treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis published in the European Respiratory Journal
    • 30 Oct 2019 According to an Aradigm Corporation media release, the company has withdrawn its Marketing Authorization Application (MAA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa. The decision came after the company learned that the CHMP was likely to formally adopt a negative opinion in its evaluation of the application.
    • 21 Feb 2019 According to an Aradigm media release, in a Type B meeting with the FDA, the company presented the results of the Third Party Evaluation (TPE) completed in December 2018 that addressed the clinical issue raised by the FDA in the complete response letter (CRL) received in January 2018. Following FDA guidance provided in a Type C meeting, a new Human Factor study and work to address the product quality deficiencies are currently nearing completion.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top