At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
TOBIdrug
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.
Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
In Brief
A Phase 1 clinical trial evaluating TOBI for Cystic Fibrosis and Burkholderia Cepacia Infection. Completed, enrolled 10 participants across 2 sites.
Detailed Summary
The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Burkholderia Cepacia Infection
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartSep 2014
Primary CompletionMay 2016
TodayJul 2026
First PostedAug 8, 2014
Enrollment StartSep 1, 2014
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.9 years ago
Interventions
TOBIdrug
New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler