MedTrace Logo

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

NCT00388505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2012-07-24

Study results available
· View outcomes & findings →

Summary

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Conditions

Interventions

DRUG

Tobramycin Inhalation Powder

Tobramycin Inhalation Powder (TIP) capsules for inhalation.

DRUG

Tobramycin Solution for Inhalation

Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer

Sponsors & Collaborators

Principal Investigators

  • Michael Konstan, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00388505 on ClinicalTrials.gov