The long-term use of inhaled tobramycin in patients with cystic fibrosis

J Cyst Fibros. 2002 Dec;1(Suppl 2):194-8. doi: 10.1016/s1569-1993(02)00003-6.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Age Factors
  • Anti-Bacterial Agents / administration & dosage*
  • Child
  • Cystic Fibrosis / complications*
  • Double-Blind Method
  • Female
  • Humans
  • Lung Diseases / drug therapy
  • Male
  • Pseudomonas Infections / drug therapy*
  • Time Factors
  • Tobramycin / administration & dosage*
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Tobramycin