Pneumologie 2016; 70 - P252
DOI: 10.1055/s-0036-1572092

Safety and tolerability of once-daily tiotropium Respimat® add-on to at least inhaled corticosteroid maintenance therapy in adolescent patients with moderate or severe symptomatic asthma

E Beck 1, R Dahl 2, SJ Szefler 3, J Bernstein 4, M Vandewalker 5, M Engel 6, P Moroni-Zentgraf 6, A Unseld 7, E Hamelmann 8
  • 1Institute for Health Promotion
  • 2Allergy Centre, Odense University Hospital
  • 3Department of Pediatrics, Children's Hospital of Colorado and the University of Colorado Denver School of Medicine
  • 4Department of Internal Medicine, Division of Immunology/Allergy Section, University of Cincinnati College of Medicine and Bernstein Cliical Research Center
  • 5Clinical Research of the Ozarks
  • 6Ta Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. Kg
  • 7Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH & Co. Kg
  • 8Allergy-Center-Ruhr, Ev. Hospital Bielefeld and Ruhr-University Bochum

Background: Once-daily tiotropium Respimat® add-on to at least ICS has demonstrated efficacy, safety and tolerability in adult patients across severities of asthma. We assess the safety and tolerability of once-daily tiotropium Respimat® in adolescent patients aged 12 – 17 years with moderate or severe symptomatic asthma.

Method: Two Phase III, randomised, double-blind, parallel-group trials. RubaTinA-asthma® (NCT01257230): once-daily tiotropium Respimat® 5 µg or 2.5 µg or placebo Respimat® add-on to medium-dose ICS (12 – 14 years: 200 – 400 µg budesonide or equivalent [bud or eq]; 14 – 17 years: 400 – 800 µg bud or eq)± LTRA in adolescents with moderate asthma over 48 weeks; PensieTinA-asthma® (NCT01277523): once-daily tiotropium Respimat® 5 µg or 2.5 µg or placebo Respimat® add-on to high-dose ICS (12 – 14 years: > 400 µg bud or eq; 14 – 17 years: > 800 – 1600 µg bud or eq) + ≥1 controller or medium-dose ICS + ≥2 controllers in adolescents with severe asthma over 12 weeks. AEs included in the analysis were recorded during the treatment period + 30 days.

Results: 397 patients received treatment in RubaTinA-asthma® and 392 in PensieTinA-asthma®. The frequency of AEs and serious AEs was comparable between treatment groups in the studies, drug-related AEs were rare, and most AEs were mild or moderate in intensity. No deaths occurred. The most commonly reported AEs, by preferred term (MedDRA version 16.1), were asthma (20.7%), nasopharyngitis (12.6%) and viral respiratory tract infection (8.1%) in RubaTinA-asthma®, and asthma (11.0%), reduced PEF rate (6.9%) and nasopharyngitis (3.8%) in PensieTinA-asthma®.

Conclusion: Once-daily tiotropium Respimat® add-on to at least ICS maintenance therapy had comparable safety and tolerability with placebo Respimat® in adolescent patients with moderate or severe symptomatic asthma.

Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.

Presented at EAACI 2015