PT  - JOURNAL ARTICLE
AU  - Christian Vogelberg
AU  - Stanley J. Szefler
AU  - Elianne J.L.E. Vrijlandt
AU  - Attilio L. Boner
AU  - Michael Engel
AU  - Georges El Azzi
AU  - Sebastian Dan Vulcu
AU  - Petra M. Moroni-Zentgraf
AU  - Olaf Eickmeier
AU  - Eckard H. Hamelmann
TI  - Tiotropium add-on therapy is safe and reduces seasonal worsenings in paediatric asthma patients
AID  - 10.1183/13993003.01824-2018
DP  - 2019 Jan 01
TA  - European Respiratory Journal
PG  - 1801824
4099  - http://erj.ersjournals.com/content/early/2019/03/15/13993003.01824-2018.short
4100  - http://erj.ersjournals.com/content/early/2019/03/15/13993003.01824-2018.full
AB  - 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 µg 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%), 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 gender. 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.Clinical Trial Registration: NinoTinA-asthma® (NCT01634113), CanoTinA-asthma® (NCT01634139), VivaTinA-asthma® (NCT01634152), RubaTinA-asthma® (NCT01257230), PensieTinA-asthma® (NCT01277523).FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Szefler reports other from Boehringer-Ingelheim, other from Genentech, other from GlaxoSmithKline, other from Aerocrine, other from Novartis, other from Astra Zeneca, other from Daiichi Sankyo, other from Roche, grants from GlaxoSmithKline, other from Teva, outside the submitted work.Conflict of interest: Dr. Vrijlandt has nothing to disclose.Conflict of interest: Dr. Boner has nothing to disclose.Conflict of interest: Dr. Engel reports and Employee of Boehringer Ingelheim.Conflict of interest: Dr. Moroni-Zentgraf reports other from Boehringer Ingelheim, during the conduct of the study; other from Boehringer Ingelheim, outside the submitted work; and Employee of Boehringer Ingelheim.Conflict of interest: Dr. Eickmeier reports other from Boehringer Ingelheim International GmbH, during the conduct of the study.Conflict of interest: Dr. Hamelmann has nothing to disclose.Conflict of interest: Dr. El Azzi reports other from Boehringer Ingelheim, during the conduct of the study; other from Boehringer Ingelheim, outside the submitted work; and Employee of Boehringer Ingelheim.Conflict of interest: Dr. Vulcu reports other from Boehringer Ingelheim, during the conduct of the study; other from Boehringer Ingelheim, outside the submitted work; and Employee of Boehringer Ingelheim.Conflict of interest: Dr. Vogelberg reports other from Boehringer Ingelheim, during the conduct of the study; personal fees from Boehringer Ingelheim, personal fees from Novartis, outside the submitted work.