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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: Trial Completed
Study Drug(s): Tobramycin Inhalation Powder
Number of Participants Being Recruited: 200
Single / Multi-Center: Multi-Center
This is a phase 4 study that will compare two different treatments for Pseudomonas aeruginosa. This trial will look to see if it is more effective to take TIP once a day continuously or to alter on and off of TIP twice a day four weeks at a time.
This trial is for people with cystic fibrosis who have P. aeruginosa. The trial will require lung function tests. It is for people who are ages 6 and older.
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 If a specific trial listing for this trial is available, a link to the specific listing will be present in the "More Information" section below.
Sponsor Contact Information:
Trial Specific Link on
Clinical Research Terms Glossary: Click here
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.
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Vajda, Natalie
        Phone: (323) 361-3255
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
  • University of Miami (Pediatric), Miami, FL, 33136
    Contact Information:
        Mendes, Eliana
        Phone: (305) 243-2568
  • Central Florida Pulmonary Group (Adult), Orlando, FL, 32803
    Contact Information:
        Kesser, Kenneth (Bert)
        Phone: (407) 841-1100 X118
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
  • Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
    Contact Information:
        Cooper, Amy
        Phone: (314) 678-5457
  • Morristown Medical Center (Adult), Morristown, NJ, 07962
    Contact Information:
        Martinez, Nancy
        Phone: (973) 971-5138
  • The Steven & Alexandra Cohen Children's Medical Center of New York (Pediatric), Great Neck, NY, 11021
    Contact Information:
        Galvin, Susan
        Phone: (516) 622-5281
  • New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
    Contact Information:
        Gherson, Ingrid
        Phone: (914) 594-2348
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
  • Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
    Contact Information:
        Brazil, Isolde
        Phone: (512) 380-9200 X65343
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
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