A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

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

    • 27 Oct 2011 Additional lead trial centre identified as reported by Clinical Trials Registry - India record.
    • 07 Jun 2011 Actual end date (May 2011) added as reported by ClinicalTrials.gov.
    • 07 Jun 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.(NCT00918957).
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