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

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

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2015

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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    • 05 Feb 2015 Status changed from planning to withdrawn prior to enrolment.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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