At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
Tobramycin inhalation powderdrug
Likely dose
Tobramycin inhalation powder 112 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 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) Subjects Who Completed Participation in Study CTBM100C2303.
In Brief
A Phase 3 clinical trial evaluating Tobramycin inhalation powder for Pseudomonas Aeruginosa and Cystic Fibrosis. Completed, enrolled 55 participants across 2 sites in 2 countries.
Detailed Summary
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPseudomonas Aeruginosa, Cystic Fibrosis
CountriesEstonia, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionOct 2011
Study CompletionOct 2011
TodayJul 2026
First PostedSep 23, 2009
Enrollment StartAug 12, 2009
Primary CompletionOct 1, 2011
Study CompletionOct 6, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.8 years ago
Interventions
Tobramycin inhalation powderdrug
Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.