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Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

NCT ID: NCT00125346

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tobramycin Inhalation Powder

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
* Male and female subjects between 6 and 21 years of age at the time of screening.
* FEV1 at screening must be between 25% and 80% of normal predicted values.

Exclusion Criteria

* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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novartis

Locations

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For information on a site near you, call 1-800-244-7668 Option "2"

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Fresno, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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Sacramento, California, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Oak Lawn, Illinois, United States

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Ann Arbor, Michigan, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Valhalla, New York, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Morgantown, West Virginia, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Curitiba, Paraná, Brazil

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Florianópolis, Santa Catarina, Brazil

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Campinas, São Paulo, Brazil

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Varna, , Bulgaria

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Santiago, , Chile

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Viña del Mar, , Chile

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Vilnius, , Lithuania

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Mexico City, , Mexico

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Monterrey, , Mexico

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Tijuana, , Mexico

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Countries

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United States Argentina Brazil Bulgaria Canada Chile Lithuania Mexico

Other Identifiers

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CTBM100C2301

Identifier Type: -

Identifier Source: org_study_id