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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.
CA
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Vajda, Natalie
        Phone: (323) 361-3255
        Email: nvajda@chla.usc.edu
FL
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
        Email: Elizabeth.DeLuca@nemours.org
  • Central Florida Pulmonary Group (Adult), Orlando, FL, 32803
    Contact Information:
        Kesser, Kenneth (Bert)
        Phone: (407) 841-1100 X118
        Email: bkesser@cfpulmonary.com
IA
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
IN
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.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
NJ
  • Morristown Medical Center (Adult), Morristown, NJ, 07962
    Contact Information:
        Martinez, Nancy
        Phone: (973) 971-5138
        Email: nancy.martinez@atlantichealth.org
NY
  • The Steven & Alexandra Cohen Children's Medical Center of New York (Pediatric), Great Neck, NY, 11021
    Contact Information:
        Galvin, Susan
        Phone: (516) 622-5281
        Email: sgalvin@nshs.edu
OH
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
OR
  • Oregon Health Sciences University (Pediatric), Portland, OR, 97201
    Contact Information:
        Simmons, Kim
        Phone: (503) 494-7807
        Email: simmonsk@ohsu.edu
PA
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
        Email: dkitch@psu.edu
  • 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
TX
  • Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
    Contact Information:
        Brazil, Isolde
        Phone: (512) 380-9200 X65343
        Email: IBrazil@seton.org
UT
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
        Email: jane.vroom@hsc.utah.edu
VA
  • Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
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