The long-term use of inhaled tobramycin in patients with cystic fibrosis.
Tobramycin nebuliser solution (TNS) has been investigated in several clinical trials, including a large, placebo-controlled study that demonstrated efficacy over a 24-week period. The open-label extension phase of this trial enabled observations to be conducted for an additional period of almost 18 months. Patients from both treatment arms (n=396) entered the open-label phase and received up to nine 28-day on, 28-day off cycles of TNS 300 mg by aerosol twice daily (b.i.d.). Mean lung function in patients who had received placebo during the double-blind phase improved during the first three cycles of the open-label treatment. However, lung function in these patients did not recover to the levels seen in those patients who had received TNS throughout the double-blind and open-label phases. In both groups of patients, improvement was maintained during the study. Greater improvements were seen in adolescents compared with older patients. Adverse events were generally uncommon, with a notably lower incidence of fever, anorexia, abdominal pain and vomiting than was observed in the double-blind phase among patients who received placebo, and a generally low incidence of tinnitus. We conclude that long-term TNS administration is safe and effective.
Division of Pediatric Pulmonology, 135 Rutledge Ave, Rm. 281, P.O. Box 250561, Charleston, SC 29425, USA. bowmanm@musc.edu
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D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002648:Child; D003550:Cystic Fibrosis / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000188:drug therapy; D008297:Male; D011552:Pseudomonas Infections / Q000188:drug therapy*; D013997:Time Factors; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D014031:Tobramycin