At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 157 enrolled
Drug / intervention
TBM100drug
Likely dose
TBM100 28mgfrom 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 Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis
In Brief
A Phase 4 clinical trial evaluating TBM100 for Pulmonary Infections and Pseudomonas Aeruginosa in Cystic Fibrosis. Completed, enrolled 157 participants across 49 sites in 10 countries.
Detailed Summary
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Canada, France, Germany, Hungary, Italy, Mexico, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedJan 27, 2012
Enrollment StartJan 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.4 years ago
Interventions
TBM100drug
Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.