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P155 Safety of tiotropium respimat® add-on therapy in patients aged 6–17 years with symptomatic asthma
  1. C Vogelberg1,
  2. SJ Szefler2,
  3. E Hamelmann3,
  4. A Boner4,
  5. P Moroni-Zentgraf5,
  6. M Engel5,
  7. G El Azzi5,
  8. H Finnigan6,
  9. M Vandewalker7
  1. 1University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany
  2. 2Department of Paediatrics, Children’s Hospital of Colorado and the University of Colorado Denver School of Medicine, Aurora, CO, USA
  3. 3Evangelisches Krankenhaus Bielefeld, and Allergy Centre of the Ruhr University, Bochum, Germany
  4. 4Paediatric Department, University of Verona, Verona, Italy
  5. 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim am Rhein, Germany
  6. 6Biostatistics and Data Sciences, Boehringer Ingelheim Ltd, Bracknell, UK
  7. 7Clinical Research of the Ozarks, Inc., Columbia, MO, USA

Abstract

Introduction and objectives Two Phase II trials have shown tiotropium Respimat® (tioR) to be a well-tolerated bronchodilator in patients aged 12–171 and 6–112 years with symptomatic asthma. Here, we further assessed the safety and tolerability of once-daily (QD) tioR add-on therapy in Phase III trials in patients aged 6–17 years with symptomatic asthma.

Methods Data was analysed from three completed Phase III, randomised, double-blind, placebo-controlled, parallel-group trials: VivaTinA (NCT01634152), 12-week trial, patients aged 6–11 years; PensieTinA (NCT01277523), 12-week trial, patients aged 12–17 years; RubaTinA (NCT01257230), 48-week trial, patients aged 12–17 years. Patients 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 years; 12–17 years.

Results 1189 patients were treated: 6–11 years, n = 400; 12–17 years, n = 789. The frequency of patients 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 inhaled corticosteroid ± other controllers, in patients aged 6–17 years with symptomatic asthma.

References

  1. Vogelberg C, et al. Respir Med 2014;108:1268–76.

  2. Vogelberg C, et al. Respir Res 2015;16:20.

Abstract P155 Table 1

Summary of adverse events in the VivaTinA-asthma, PensieTinA-asthma and RubaTinA-asthma trials

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