A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years.
Phase of Trial: Phase III
Latest Information Update: 16 Jul 2016
At a glance
- Drugs Tobramycin (Primary)
- Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
- Focus Registrational; Therapeutic Use
- Acronyms EARLY
- Sponsors Novartis Pharmaceuticals
- 24 Mar 2016 Status changed from active, no longer recruiting to completed.
- 14 Apr 2015 Planned End Date changed from 1 Sep 2015 to 1 Jul 2015 as per ClinicalTrials.gov record.
- 14 Apr 2015 Planned primary completion date changed from 1 Sep 2015 to 1 Jul 2015 as per ClinicalTrials.gov record.