An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution Versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen, in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension.

Trial Profile

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution Versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen, in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension.

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2016

At a glance

  • Drugs Aztreonam (Primary) ; Tobramycin
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 21 Apr 2012 Planned number of patients changed from 200 to 273 as reported by European Clinical Trials Database.
    • 22 Oct 2010 Gilead submitted data from this trial to the FDA in the third quarter of 2010 and plans to begin submitting data to international regulatory agencies by the end of 2010, according to a media release.
    • 21 Oct 2010 The second co-primary endpoint has been met and so aztreonam has now met the statistical definition of superiority, according to a Gilead Sciences media release.
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