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Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients.

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Trial Profile

Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Levofloxacin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Therapeutic Use
  • Sponsors Horizon Pharma USA; Mpex Pharmaceuticals
  • Most Recent Events

    • 24 May 2017 Results of pooled prespecified analysis of MPEX204,MPEX207 and MPEX209 studies presented at the 113th International Conference of the American Thoracic Society.
    • 14 Sep 2009 Top-line results have been reported in a MPEX Pharmaceuticals media release.
    • 14 Sep 2009 Primary endpoint 'bacteriological response' and 'bacteriological colonisation' has been met according to a MPEX Pharmaceuticals media release.
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