Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
tobramycin
Bacterial Infections and Mycoses+14
+ Digestive System Diseases
+ Infant, Newborn, Diseases
Treatment Study
Summary
Study start date: June 1, 1995
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 6 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening Sweat chloride at least 60 mEq/L --Prior/Concurrent Therapy-- At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic At least 4 weeks since prior administration of any investigational drug No concurrent antibiotics by aerosol --Patient Characteristics-- Renal: Creatinine less than 2 mg/dL BUN less than 40 mg/dL No proteinuria of 2+ or greater Pulmonary: FEV1 at least 75% and at least 25% of predicted Room air oximetry at least 88% saturation Able to perform pulmonary function tests No hemoptysis of 60 mL or greater within 30 days prior to study No abnormal chest X-ray Other: Not pregnant Fertile females must use effective contraception No history of positive culture with Burkholderia cepacia No history of glucose-6-phosphate dehydrogenase deficiency No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists