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A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)

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Trial Profile

A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2019

At a glance

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

    • Most Recent Events

    • 26 Jun 2018 Planned End Date changed from 1 Apr 2019 to 1 Apr 2020.
    • 26 Jun 2018 Planned primary completion date changed from 1 Apr 2019 to 1 Apr 2020.
    • 22 Jun 2018 Planned number of patients changed from 264 to 464.
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