Tiotropium Add-on Therapy is Safe And reduces Seasonal Worsening in Paediatric asthma Patients

Overview

Journal Eur Respir J

Specialty Pulmonary Medicine

Date 2019 May 18

PMID 31097514

Citations 7

Authors

Christian Vogelberg

Stanley J Szefler

Elianne J L E Vrijlandt

Attilio L Boner

Michael Engel

Georges El Azzi

Sebastian Dan Vulcu

Petra M Moroni-Zentgraf

Olaf Eickmeier

Eckard H Hamelmann

Affiliations

Soon will be listed here.

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 µg 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.

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