A randomised dose-ranging study of tiotropium Respimat® in children with symptomatic asthma despite inhaled corticosteroids

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Christian Vogelberg - , Department of Paediatrics, TUD Dresden University of Technology (Author)
  • Petra Moroni-Zentgraf - , Boehringer Ingelheim GmbH (Author)
  • Migle Leonaviciute-Klimantaviciene - , Vilnius University (Author)
  • Ralf Sigmund - , Boehringer Ingelheim GmbH (Author)
  • Eckard Hamelmann - , Epilepsy Center Bethel (Author)
  • Michael Engel - , Boehringer Ingelheim GmbH (Author)
  • Stanley Szefler - , University of Colorado Denver (Author)

Abstract

Background: A considerable number of children with asthma remain symptomatic despite treatment with inhaled corticosteroids, resulting in significant morbidity, reduced quality of life, increased healthcare costs and lost school days. The aim of our study was to assess the efficacy, safety and tolerability of once-daily tiotropium Respimat® 5 μg, 2.5 μg and 1.25 μg add-on to medium-dose inhaled corticosteroids, with or without a leukotriene modifier, in children aged 6-11 years with symptomatic asthma. Methods: In this Phase II, double-blind, placebo-controlled, incomplete-crossover, dose-ranging study, patients were randomised to receive three of the four treatments evaluated: once-daily tiotropium Respimat® 5 μg, 2.5 μg or 1.25 μg or placebo Respimat®, in the evening during the 12-week (three × 4-week) treatment period. Results: In total, 76, 74, 75 and 76 patients aged 6-11 years received tiotropium Respimat® 5 μg, 2.5 μg, 1.25 μg and placebo Respimat®, respectively. For the primary end point (peak forced expiratory volume in 1 second measured within 3 hours post-dosing), the adjusted mean responses with tiotropium Respimat® 5 μg (272 mL), 2.5 μg (290 mL) and 1.25 μg (261 mL) were significantly greater than with placebo Respimat® (185 mL; p = 0.0002, p < 0.0001 and p = 0.0011, respectively). The safety and tolerability of all doses of tiotropium Respimat® were comparable with those of placebo Respimat®, with no serious adverse events and no events leading to discontinuation. Conclusions: Tiotropium Respimat® add-on to medium-dose inhaled corticosteroids, with or without a leukotriene modifier, was efficacious in paediatric patients with symptomatic asthma and had comparable safety and tolerability with placebo Respimat®.

Details

Original languageEnglish
Article number20
JournalRespiratory Research
Volume16
Issue number1
Publication statusPublished - 7 Feb 2015
Peer-reviewedYes

External IDs

Scopus 84927717677
PubMed 25851298

Keywords

ASJC Scopus subject areas

Keywords

  • Asthma, Asthma control, Children, Lung function, Once-daily, Paediatric, Respimat®, Tiotropium