CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled
Drug / intervention
Tobramycin solution for inhalation 300 mgdrug
Likely dose
Tobramycin solution for inhalation 300 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.

Search/NCT00391976
NCT00391976Phase 3Completed
CompareCT.gov

The Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis

Novartis·interventional·Posted Oct 25, 2006·Updated Aug 29, 2011

In Brief

A Phase 3 clinical trial evaluating Tobramycin solution for inhalation 300 mg for Cystic Fibrosis. Completed, enrolled 123 participants.

Detailed Summary

This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution. The safety profile of the initial tobramycin treatment was assessed during the first 3 months of the study and patients were followed until the end of the study, month 27.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2006
Enrollment StartNov 1, 2003
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 19.7 years ago

Interventions

Tobramycin solution for inhalation 300 mgdrug

Tobramycin solution for inhalation was supplied in 5 mL liquid-filled low-density polyethylene ampoules containing 300 mg tobramycin. Patients used a nebulizer to inhale the contents of the ampoules.