RT Journal Article
SR Electronic
T1 Effect of inhalation of tobramycin on reduction of hospitalisation rate in severe COPD
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2894
VO 40
IS Suppl 56
A1 Peter Haidl
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2894.abstract
AB Introduction: Exacerbation in severe COPD often requires hospital treatment and has a negative impact on patients prognosis. An important cause of frequent exacerbations is lower airway bacterial colonization in stable disease. In addition moderate bronchiectasis are present in up to 50% in severe COPD. The study investigated the effect of daily inhalation of tobramycin on hospitalisation rate in severe COPD.Methods: At six centers we randomly assigned 44 patients (30 males) with severe COPD (FEV 1 of predicted value 42.8 ±7.1 Tobra and 33.5±10.3 placebo) and a minimum of two hospitalisations in the year before inclusion. Patients inhaled twice daily for 12 months 80 mg tobramycin (GERNEBCIN®) or isotonic saline (placebo) with a jet nebulizer (Pari Boy SX). Primary endpoint was hospitalisation rate in the period of study, secondary endpoints time to first hospitalisation and 6 MWD.Results:View this table:[table1]ITT1 = number of patients which took study medication for at least 28 daysConclusion:Inhalation with 160 mg tobramycin by means of a nebulizer over a 12 month period didn't reduce the hospitalisation rate for patients with severe COPD and a minimum of two hospitalisations compared to placebo. The statistical relevance is reduced by a high drop-out rate specifically in the tobramycin-group unrelated to side effects during inhalation of tobramycin. However, the underlying reason remains unexplained.