Safety of tiotropium Respimat add-on therapy in patients aged 6 – 17 years with symptomatic asthma
23. Februar 2017 (online)
Two Phase II trials have shown tiotropium Respimat® (tioR) to be a well-tolerated bronchodilator in patients (pts) aged 12 – 171 and 6 – 112 years (yrs) with symptomatic asthma.
To further assess safety and tolerability of once-daily (QD) tioR add-on therapy in Phase III trials in pts aged 6 – 17yrs with symptomatic asthma.
Data analysed from 3 completed Phase III, randomised, double-blind, placebo-controlled, parallel-group trials: VivaTinA (NCT01634152), 12-week trial, pts aged 6 – 11yrs; PensieTinA (NCT01257230), 12-week trial, pts aged 12 – 17yrs; RubaTinA (NCT01277523), 48-week trial, pts aged 12 – 17yrs. Pts received QD tioR 5 µg (2 puffs, 2.5 µg), QD tioR 2.5 µg (2 puffs, 1.25 µg) or QD placebo Respimat® (pboR; 2 puffs) as add-on to background therapy. Adverse events (AEs) were recorded and analysed descriptively by age: 6 – 11yrs; 12 – 17yrs.
1189 pts were treated: 6 – 11yrs, n = 400; 12 – 17yrs, n = 789. The frequency of pts with AEs was similar across all treatment arms, with a low incidence of drug-related and serious AEs; asthma and decreased peak expiratory flow rate were the most common AEs. No deaths occurred.
The AE profile and AE incidences were similar between tioR 5 µg, tioR 2.5 µg and pboR, as add-on to ICS ± other controllers, in pts aged 6 – 17yrs with symptomatic asthma.
 Vogelberg et al. Respir Med 2014;108:1268 – 76
 Vogelberg et al. Respir Res 2015;16:20
Content already presented at ERS congress 2016