A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2016

At a glance

  • Drugs Tobramycin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms EARLY
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 24 Mar 2016 Status changed from active, no longer recruiting to completed.
    • 14 Apr 2015 Planned End Date changed from 1 Sep 2015 to 1 Jul 2015 as per ClinicalTrials.gov record.
    • 14 Apr 2015 Planned primary completion date changed from 1 Sep 2015 to 1 Jul 2015 as per ClinicalTrials.gov record.
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