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Terminated Phase 3 Interventional

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

ClinicalTrials.gov ID: NCT00125346

Public ClinicalTrials.gov record NCT00125346. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 9:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00125346
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
98 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2005
Primary completion
Jan 31, 2007
Completion
Jan 31, 2007
Last update posted
Oct 11, 2011

2005 – 2007

United States locations

U.S. sites
26
U.S. states
16
U.S. cities
26
Facility City State ZIP Site status
For information on a site near you, call 1-800-244-7668 Option "2" Mobile Alabama
For information on a site near you, call 1-800-244-7668 Option "2" Phoenix Arizona
For information on a site near you, call 1-800-244-7668 Option "2" Fresno California
For information on a site near you, call 1-800-244-7668 Option "2" Long Beach California
For information on a site near you, call 1-800-244-7668 Option "2" Los Angeles California
For information on a site near you, call 1-800-244-7668 Option "2" Oakland California
For information on a site near you, call 1-800-244-7668 Option "2" Sacramento California
For information on a site near you, call 1-800-244-7668 Option "2" Orlando Florida
For information on a site near you, call 1-800-244-7668 Option "2" Pensacola Florida
For information on a site near you, call 1-800-244-7668 Option "2" Atlanta Georgia
For information on a site near you, call 1-800-244-7668 Option "2" Augusta Georgia
For information on a site near you, call 1-800-244-7668 Option "2" Chicago Illinois
For information on a site near you, call 1-800-244-7668 Option "2" Oak Lawn Illinois
For information on a site near you, call 1-800-244-7668 Option "2" Ann Arbor Michigan
For information on a site near you, call 1-800-244-7668 Option "2" New Hyde Park New York
For information on a site near you, call 1-800-244-7668 Option "2" New York New York
For information on a site near you, call 1-800-244-7668 Option "2" Valhalla New York
For information on a site near you, call 1-800-244-7668 Option "2" Durham North Carolina
For information on a site near you, call 1-800-244-7668 Option "2" Cleveland Ohio
For information on a site near you, call 1-800-244-7668 Option "2" Columbus Ohio
For information on a site near you, call 1-800-244-7668 Option "2" Oklahoma City Oklahoma
For information on a site near you, call 1-800-244-7668 Option "2" Philadelphia Pennsylvania
For information on a site near you, call 1-800-244-7668 Option "2" Charleston South Carolina
For information on a site near you, call 1-800-244-7668 Option "2" Tyler Texas
For information on a site near you, call 1-800-244-7668 Option "2" Salt Lake City Utah
For information on a site near you, call 1-800-244-7668 Option "2" Morgantown West Virginia

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00125346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 11, 2011 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00125346 live on ClinicalTrials.gov.

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