Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects
Stopped early · Phase 3
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT00125346
- Run by
- Novartis
- People needed
- 98
- Starts
- 2005-09-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2011-10-12
Who can join
Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Where it is running
- For information on a site near you, call 1-800-244-7668 Option "2" — Mobile, Alabama, United States
- For information on a site near you, call 1-800-244-7668 Option "2" — Phoenix, Arizona, United States
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- For information on a site near you, call 1-800-244-7668 Option "2" — Oak Lawn, Illinois, United States
- For information on a site near you, call 1-800-244-7668 Option "2" — Ann Arbor, Michigan, United States
- For information on a site near you, call 1-800-244-7668 Option "2" — New Hyde Park, New York, United States
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- For information on a site near you, call 1-800-244-7668 Option "2" — Valhalla, New York, United States
- For information on a site near you, call 1-800-244-7668 Option "2" — Durham, North Carolina, United States
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- For information on a site near you, call 1-800-244-7668 Option "2" — Philadelphia, Pennsylvania, United States
- For information on a site near you, call 1-800-244-7668 Option "2" — Charleston, South Carolina, United States
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- For information on a site near you, call 1-800-244-7668 Option "2" — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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