At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
Tobramycin inhalation powderdrug
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 Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Successfully Completed Participation in Study CTBM100C2303E1
In Brief
A Phase 3 clinical trial evaluating Tobramycin inhalation powder for Pulmonary Infections and Pseudomonas Aeruginosa. Completed, enrolled 49 participants across 17 sites in 7 countries.
Detailed Summary
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Infections, Pseudomonas Aeruginosa
CountriesBulgaria, Estonia, Latvia, Lithuania, Romania, Russia, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionMar 2012
TodayJul 2026
First PostedFeb 17, 2010
Enrollment StartFeb 12, 2010
Primary CompletionMar 19, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.4 years ago
Interventions
Tobramycin inhalation powderdrug
Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.