Planned phase III trial of inhaled amikacin in patients with cystic fibrosis who have chronic Psuedomonas lung infections (a revised patient population).

Trial Profile

Planned phase III trial of inhaled amikacin in patients with cystic fibrosis who have chronic Psuedomonas lung infections (a revised patient population).

Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2015

At a glance

  • Drugs Amikacin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 05 Feb 2015 Status changed from planning to withdrawn prior to enrolment. This trial was planned to replace TR02-109 in a revised patient population, but appears not to have been conducted.
    • 09 May 2012 The US FDA lifts a clinical hold on trials of inhaled amikacin.
    • 09 May 2012 New trial record
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