Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

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