Status:
TERMINATED
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects
Lead Sponsor:
Novartis
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-21 years
Phase:
PHASE3
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00125346
Start Date
September 1 2005
End Date
February 1 2007
Last Update
October 12 2011
Active Locations (41)
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1
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Mobile, Alabama, United States
2
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Phoenix, Arizona, United States
3
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Fresno, California, United States
4
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Long Beach, California, United States