CFF - Tobramycin Inhalation Powder (TIP) in People with Cystic Fibrosis

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Clinical Research Information Sheet

Study Name:

Tobramycin Inhalation Powder (TIP) in People with Cystic Fibrosis

Study Type:

Interventional

Intervention Category:

Anti-Infective

Study Sponsor:

Novartis

Study Phase:

Recruitment Status:

Recruiting

Study Drug(s):

Tobramycin Inhalation Powder

Number of Participants Being Recruited:

150

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

This study will assess the long term safety for the use of tobramycin inhalation powder (TIP) in people with cystic fibrosis who have a chronic pulmonary infection with Pseudomonas Aeruginosa.

ELIGIBILITY

Age:	>= 6 Weeks
FEV1:	25 - 75 Percent Predicted
P. aeruginosa status:	Positive
B. cepacia status:	Negative
Other Primary Eligibility Requirements:
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://www.clinicaltrials.gov/ct2/show/NCT01519661?term=TIP+and+cystic+fibrosis&rank=2

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.

University of Arkansas for Medical Sciences (Adult), Little Rock, AR, 72205
Contact Information:
    Taggart, Adam
    Phone: (501) 416-7019
    Email: agtaggart@uams.edu

National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
    Jones, Marion
    Phone: (303) 398-1265
    Email: jonesm@njhealth.org

Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
Contact Information:
    DeLuca, Elizabeth
    Phone: (904) 697-3804
    Email: bdeluca@nemours.org

Emory University (Pediatric), Atlanta, GA, 30322
Contact Information:
    Hunter, Eric
    Phone: (404) 727-9960
    Email: eahunte@emory.edu

St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Rodgers, Denise
    Phone: (314) 286-1176
    Email: rodgers@kids.wustl.edu
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Burks, Patricia
    Phone: (314) 454-5175
    Email: Burks_P@kids.wustl.edu

University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
    Acquazzino, Diane
    Phone: (402) 559-6275
    Email: dracquaz@unmc.edu
University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
    Telfer, Raquel
    Phone: (402) 559-6275
    Email: raquel.telfer@unmc.edu

Goryeb Children's Hospital of Atlantic Health (Adult), Morristown, NJ, 07962
Contact Information:
    Cahill, Carol
    Phone: (973) 971-5138
    Email: carol.cahill@atlantichealth.org

Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
Contact Information:
    Ouellette, Deborah
    Phone: (330) 543-3089
    Email: douellette@chmca.org
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

Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
Contact Information:
    Fox, Jodie
    Phone: (405) 271-6216
    Email: Jodie-Fox@ouhsc.edu

Medical University of South Carolina (Adult), Charleston, SC, 29425
Contact Information:
    Warden, Ashley
    Phone: (843) 792-4349
    Email: jonesash@musc.edu

Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
Contact Information:
    Morris, Trudy
    Phone: (682) 885-1244
    Email: Trudy.Morris@cookchildrens.org
Baylor College of Medicine (Pediatric), Houston, TX, 77030
Contact Information:
    Schaap, Nicoline
    Phone: (832) 822-4252
    Email: nxschaap@texaschildrens.org
Christus Santa Rose Children's Hospital (Adult), San Antonio, TX, 78212
Contact Information:
    Phillips, Teresa
    Phone: (210) 223-3010
    Email: tphillips@acra-sa.com

Froedtert & Medical College of Wisconsin (Adult), Milwaukee, WI, 53201
Contact Information:
    Harris, Rachel
    Phone: (414) 955-7030
    Email: racharris@mcw.edu