drugset / Trial / NCT00125346

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

NCT00125346 ↗

Phase 3 Terminated 98 enrolled Novartis
RandomizedDouble-blindTreatment

Summary

Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.

Timeline

Start
2005-09
Primary completion
2007-02
Completion
2007-02

Outcome

Outcome not reported

Stopped: “per Data Monitoring Committee recommendation”

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobramycin Unknown — Inhaled

Indications