Inhalation von Tobramycin über 12 Monate zur Senkung der Hospitalisationsrate bei schwerer COPD mit gehäuften Hospitalisationen^[*]

Zusammenfassung

Fragestellung: Eine bakterielle Kolonisation im stabilen Intervall der COPD und Bronchiektasen können Ursachen für wiederholte, prognostisch ungünstige Hospitalisationen sein. Die Studie untersuchte den Einfluss der Inhalation von Tobramycin auf die Häufigkeit von Hospitalisationen bei Patienten mit COPD und mindestens 2 Hospitalisationen im Jahr vor Studieneinschluss.

Methode: 44 Patienten mit COPD (FEV₁% Sollwert: 42,8 ± 7,1 Tobramycin (T); 33,5 ± 10,3 Placebo (P)) inhalierten (randomisiert, doppelblind) über ein Jahr täglich zweimal 80 mg Tobramycin oder Placebo „add on“ zur Guideline-Therapie. Primärer Endpunkt: Zahl der COPD-Hospitalisationen. Sekundäre Endpunkte: Lungenfunktion und 6-Minuten-Gehstrecke.

Ergebnisse: In der T-Gruppe betrug die Zahl der COPD-Hospitalisationen 2,8 ± 0,5 im Jahr vor Studieneinschluss und 3,5 ± 2,7 im Studienjahr, in der P-Gruppe 3,0 ± 1,4 und 2,3 ± 2,2. Der Unterschied war nicht signifikant, ebenso nicht für die sekundären Endpunkte. Hohe Abbruchrate mit 24 von 44 Patienten. Nur 6 Patienten in der T- und 14 Patienten in der P-Gruppe beendeten die Studie protokollgerecht.

Schlussfolgerung: Die 12-monatige tägliche Inhalation von 160 mg Tobramycin mit einem Vernebler führte nicht zu einer Reduktion der Zahl der Hospitalisationen im Vergleich zu Placebo. Die hohe Abbruchrate war überwiegend bedingt durch die Schwere der Grunderkrankung.

Abstract

Introduction: 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.

Conclusion: 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.

^* Der Beitrag ist Prof. Dr. med. Dieter Köhler zum 65. Geburtstag gewidmet.

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