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Study Name: Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered Twice a Day Cycled
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Novartis
Study Phase: 4
Recruitment Status: Recruiting
Study Drug(s): Tobramycin Inhalation Powder
Number of Participants Being Recruited: 200
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this study is to provide effectiveness and safety data on two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.
ELIGIBILITY
Age: >= 6 Years
FEV1: 25 - 80 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2)
Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
Use of loop diuretics within 7 days prior to study drug administration
Administration of any investigational drug within 30 days prior to enrollment or 5 halflives, whichever is longer
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT02015663
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
IA
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
MO
  • Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
    Contact Information:
        Cooper, Amy
        Phone: (314) 678-5457
        Email: acoope16@slu.edu
PA
  • University of Pennsylvania Hospital (Adult), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.edu
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
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