At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 45 enrolled
Drug / intervention
TBM100drug
Likely dose
TBM100 112mgfrom 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 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.
In Brief
A Phase 4 clinical trial evaluating TBM100 for Long-term Safety of TIP. Completed, enrolled 45 participants across 21 sites in 9 countries.
Detailed Summary
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLong-term Safety of TIP
CountriesArgentina, Australia, Canada, Germany, Hungary, Italy, Mexico, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionNov 2014
TodayJul 2026
First PostedJan 24, 2013
Enrollment StartFeb 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.4 years ago
Interventions
TBM100drug
Tobramycin inhalation powder (TIP) 112mg/b.i.d