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Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

NCT00634192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-02-24

No results posted yet for this study

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).

Conditions

  • Pseudomonas Infections

Interventions

DRUG

tobramycin

1x300mg/d inhaled

DRUG

tobramycin

2x300mg/d inhaled

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma AG · Novartis Pharmaceuticals

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-02-28
Completion
2009-08-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634192 on ClinicalTrials.gov