Abstract
Background: 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.
Aim: To further assess safety and tolerability of once-daily (QD) tioR add-on therapy in Phase III trials in pts aged 6-17 yrs with symptomatic asthma.
Methods: Data analysed from 3 completed Phase III, randomised, double-blind, placebo-controlled, parallel-group trials: VivaTinA (NCT01634152), 12-week trial, pts aged 6-11 yrs; PensieTinA (NCT01257230), 12-week trial, pts aged 12-17 yrs; RubaTinA (NCT01277523), 48-week trial, pts aged 12-17 yrs. 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: 6-11 yrs; 12-17 yrs.
Results: 1189 pts were treated: 6-11 yrs, n=400; 12-17 yrs, 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 (Table). No deaths occurred.
Conclusion: 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 6-17 yrs with symptomatic asthma.
1. Vogelberg et al. Respir Med 2014;108:1268-76
2. Vogelberg et al. Respir Res 2015;16:20
- Copyright ©the authors 2016
