A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Status:
Completed
Trial end date:
2002-02-01
Target enrollment:
Participant gender:
Summary
This study's primary goals are to test the safety and effectiveness of Tobramycin for
Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of
age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already
been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung
fluid will be examined for bacteria before and after the 28-day treatment. The amount of
bacteria before and after treatment will be compared. This will indicate whether the
antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients
will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the
patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr
but contains no medication).
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)