Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Christian Vogelberg - , Klinik und Poliklinik für Kinder- und Jugendmedizin, Technische Universität Dresden (Autor:in)
  • Stanley J. Szefler - , University of Colorado Denver (Autor:in)
  • Elianne J.L.E. Vrijlandt - , University of Groningen (Autor:in)
  • Attilio L. Boner - , Azienda Ospedaliera Universitaria Integrata Verona (Autor:in)
  • Michael Engel - , Boehringer Ingelheim GmbH (Autor:in)
  • Georges El Azzi - , Boehringer Ingelheim GmbH (Autor:in)
  • Sebastian Dan Vulcu - , Boehringer Ingelheim GmbH (Autor:in)
  • Petra M. Moroni-Zentgraf - , Boehringer Ingelheim GmbH (Autor:in)
  • Olaf Eickmeier - , Universitätsklinikum Frankfurt (Autor:in)
  • Eckard H. Hamelmann - , Ruhr-Universität Bochum (Autor:in)

Abstract

There remains an unmet need for effective, well-tolerated therapeutic options in paediatric patients with not fully controlled asthma, for whom safety is of paramount importance. Data were pooled from five randomised, double-blind, placebo-controlled studies evaluating tiotropium 5 or 2.5 ìg versus placebo add-on therapy in patients with symptomatic asthma aged 1-17 years. Analysis included adverse events (AEs) and serious AEs (SAEs) reported throughout and for 30 days following treatment. Of 1691 patients treated, 1119 received tiotropium. Reporting of AEs was low and comparable across all groups: tiotropium 5 μg (51%), tiotropium 2.5 μg (51%) and placebo (54%). Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex. The number of AEs related to asthma symptoms and exacerbations was lower with tiotropium (5 μg) than with placebo, particularly during the seasonal peaks of these AEs. This comprehensive analysis of a large safety database allowed subgroup analyses that are often impractical with individual trials and provides further support for the safety of once-daily tiotropium Respimat add-on therapy in paediatric patients with symptomatic asthma.

Details

OriginalspracheEnglisch
Aufsatznummer1801824
FachzeitschriftEuropean Respiratory Journal
Jahrgang53
Ausgabenummer6
PublikationsstatusVeröffentlicht - 1 Juni 2019
Peer-Review-StatusJa

Externe IDs

PubMed 31097514

Schlagworte

ASJC Scopus Sachgebiete