At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 50 enrolled
Drug / intervention
TOBI +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating TOBI and Placebo for Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients. Completed, enrolled 50 participants across 19 sites in 10 countries.
Detailed Summary
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Egypt, France, Germany, Greece, Hungary, Italy, Romania, Russia, Switzerland
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartApr 2010
Primary CompletionJun 2015
TodayJul 2026
First PostedMar 8, 2010
Enrollment StartApr 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.3 years ago
Interventions
TOBIdrug
TOBI (tobramycin inhaled solution)
Placebodrug
Placebo