At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 517 enrolled
Drug / intervention
Tobramycin Inhalation Powder +1 moredrug
Likely dose
Tobramycin Solution for Inhalation 300 mgfrom 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, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects
In Brief
A Phase 3 clinical trial evaluating Tobramycin Inhalation Powder and Tobramycin Solution for Inhalation for Cystic Fibrosis. Completed, enrolled 517 participants across 72 sites in 14 countries.
Detailed Summary
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Chile, Colombia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedOct 2006
Primary CompletionMar 2009
TodayJul 2026
First PostedOct 17, 2006
Enrollment StartFeb 1, 2006
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 19.7 years ago
Interventions
Tobramycin Inhalation Powderdrug
Tobramycin Inhalation Powder (TIP) capsules for inhalation.
Tobramycin Solution for Inhalationdrug
Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer