RT Journal Article
SR Electronic
T1 LATE-BREAKING ABSTRACT: Once-daily tiotropium Respimat<sup>®</sup> add-on therapy improves lung function in children with moderate symptomatic asthma
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA4398
DO 10.1183/13993003.congress-2016.PA4398
VO 48
IS suppl 60
A1 Olaf Schmidt
A1 Eckard Hamelmann
A1 Christian Vogelberg
A1 István Laki
A1 Georges El Azzi
A1 Michael Engel
A1 Petra Moroni-Zentgraf
A1 Helen Finnigan
A1 Mark Vandewalker
YR 2016
UL http://erj.ersjournals.com/content/48/suppl_60/PA4398.abstract
AB Background: Tiotropium Respimat® (tioR) has been shown to improve lung function in a Phase II study in children with moderate symptomatic asthma.Aim: To assess the efficacy of once-daily tioR add-on therapy in a Phase III trial in patients (pts) aged 6-11 years with moderate symptomatic asthma.Methods: This 48-week, Phase III, randomised, double-blind, placebo-controlled, parallel-group study (CanoTinA-asthma®; NCT01634139) was performed in pts aged 6-11 years with moderate symptomatic asthma. Pts received once-daily tioR 5 μg (2 puffs, 2.5 µg) or 2.5 μg (2 puffs, 1.25 µg) or placebo Respimat® (pboR; 2 puffs) as add-on to background therapy (Table). Primary end point: peak FEV1 within 3 hours post-dosing (FEV1(0-3h)); secondary end points included trough FEV1 (key end point), FEV1 area under the curve (AUC)(0-3h) and peak FVC(0-3h), all measured as response (change from baseline) at Week 24.Results: Of 403 pts randomised, 401 were treated. Baseline demographics and disease characteristics were balanced between treatment groups. TioR 5 µg and 2.5 µg provided statistically significant improvements in lung function versus pboR at Week 24 (Table). The safety and tolerability of tioR were comparable with those of pboR.Conclusion: In pts aged 6-11 years with moderate symptomatic asthma, once-daily tioR add-on to ICS with or without other maintenance therapy improves lung function compared with pboR.