title: [Effect of Inhalation of Tobramycin for 12 Months on Reduction of Hospitalisation Rate in Severe COPD].
abstract: BACKGROUND
  Bacterial colonisation in stable disease of severe COPD and bronchiectasis can cause recurrent hospital treatment, which has a negative impact on the patient's prognosis. A multicentre study has investigated if daily inhalation of tobramycin for one year would lower the number of hospitalisations in severe COPD.
  
  
  METHODS
  44 patients with severe COPD [FEV1 % of predicted value: 42.8 ± 7,1 tobramycin group (T) and 33.5 ± 10.3 placebo group (P)] and a minimum of two hospitalisations in the year before inclusion were randomly assigned to inhale twice daily for 12 months 80 mg tobramycin or isotonic saline (placebo). Concomitant therapy was according to the GOLD guidelines. Primary end point was the number of hospitalisations in the period of study, secondary end points were pulmonary function test and 6 MWD.
  
  
  RESULTS
  Inhalation of T changed the number of hospitalisations from 2.8 ± 0.5 per year to 3.5 ± 2.7, P from 3.0 ± 1,4 to 2.3 ± 2.2. These differences and the results for secondary endpoints did not reach significance. The dropout rate was high, only 6 patients (T) and 14 patients (P) finished the study per protocol.
  
  
  CONCLUSIONS
  Inhalation with 160 mg tobramycin by means of a nebuliser over a 12-month period did not reduce the number of hospitalisations for patients with severe COPD and a minimum of two hospitalisations compared to placebo. The severity of the disease was the main reason for the high dropout rate.
authors.affiliation: Fachkrankenhaus Kloster Grafschaft, Abteilung Pneumologie II, Schmallenberg. p.haidl@fkkg.de
authors.forename: P
authors.initials: P
authors.lastname: Haidl
authors.forename: J
authors.initials: J
authors.lastname: Bargon
authors.forename: T
authors.initials: T
authors.lastname: Gessler
authors.forename: M
authors.initials: M
authors.lastname: Pfeifer
authors.forename: W
authors.initials: W
authors.lastname: Randerath
authors.forename: T
authors.initials: T
authors.lastname: Voshaar
authors.forename: B
authors.initials: B
authors.lastname: Wachall
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D015984:Causality; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D005858:Germany / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D015995:Prevalence; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D019141:Respiratory System Agents / Q000008:administration & dosage; D012307:Risk Factors; D012720:Severity of Illness Index; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D019141:Respiratory System Agents; D014031:Tobramycin