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A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 24 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 24 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: 11 Apr 2018

At a glance

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

    • 03 Apr 2018 Planned number of patients changed from 330 to 374.
    • 03 Apr 2018 Planned End Date changed from 1 Oct 2019 to 1 Mar 2021.
    • 03 Apr 2018 Planned primary completion date changed from 1 Oct 2019 to 1 Mar 2021.
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