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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)

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2019

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At a glance

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

    • 14 Feb 2019 Planned number of patients changed from 374 to 420.
    • 14 Feb 2019 Planned End Date changed from 1 Mar 2021 to 1 Jul 2020.
    • 14 Feb 2019 Planned primary completion date changed from 1 Mar 2021 to 1 Jul 2020.
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