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Double-blind, Placebo-controlled, Clinical Trial on Efficacy and Safety of 12-months Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa

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Trial Profile

Double-blind, Placebo-controlled, Clinical Trial on Efficacy and Safety of 12-months Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2024

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At a glance

  • Drugs Colistimethate sodium (Primary)
  • Indications Bronchiectasis; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PROMIS I
  • Sponsors Zambon SpA
  • Most Recent Events

    • 18 Jul 2023 According to a Zambon SpA Media Release, data from this study were presented at the 2023 6th World Bronchiectasis Conference in New York, NY.
    • 18 Jul 2023 Results presented in a Zambon SpA Media Release.
    • 21 Apr 2022 According to a Zambon SpA media release, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to colistimethate sodium powder for nebulization solution (CMS I-neb) for the reduction in the incidence of pulmonary exacerbations in adult patients with non-cystic fibrosis bronchiectasis (NCFB) colonized with P. aeruginosa. The BDT is supported by data from this study.
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