A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb/Actitob/Bramitob (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)

Trial Profile

A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb/Actitob/Bramitob (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2018

At a glance

  • Drugs Tobramycin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Adverse reactions
  • Sponsors Chiesi Farmaceutici
  • Most Recent Events

    • 18 Nov 2011 Actual end date for extension trial, NCT01111383 is now May 2011.
    • 18 Nov 2011 Status of extension [NCT01111383] study changed from active, no longer recruiting to completed.
    • 25 May 2011 Planned end date changed from Apr 2010 to May 2011 as reported by ClinicalTrials.gov. (Extension trial, NCT01111383).
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