Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase:
2
Recruitment Status:
Trial Completed
Study Drug(s):
TOBI
Number of Participants Being Recruited:
30
Single / Multi-Center:
Single Center
STUDY BACKGROUND INFORMATION:
Inhaled tobramycin has been reported to be highly effective at clearing Pseudomonas aeruginosa (PA) from bronchoalveolar lavage fluid (BALF) in children with cystic fibrosis (CF) age 6 moâ??6 yr, but inflammation was unaffected by this treatment, and infection occurred again for the mucoid strains of Pseudomonas. Some bacteria in the CF airway may be both inaccessible to inhaled antibiotics, and â??hiddenâ?? from BALF, by location in thick secretions, and Pseudomonas may not be effectively cleared in paranasal sinuses. This study will look at the effects of treatment with intravenous antibiotics compared to inhaled tobramycin in clearing mucoid Pseudomonas aeruginosa and reducing inflammation in the airways.
ELIGIBILITY
Age:
6 Months - 16 Years
FEV1:
Not Applicable
P. aeruginosa status:
Positive
B. cepacia status:
Not applicable
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.
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.
NC
University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
Stephenson, Kelly Phone: (919) 843-7121 Email: kelly.stephenson@unc.edu
