Overview

Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last 8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1<80% predicted).
Phase:
Phase 3
Details
Lead Sponsor:
Novartis
Treatments:
Tobramycin