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Asthma treatment
P149 Once-daily tiotropium Respimat® add-on to at least ICS in adult patients with symptomatic asthma: pooled safety analysis
  1. D Dusser1,
  2. R Buhl2,
  3. M Castro3,
  4. HAM Kerstjens4,
  5. P Paggiaro5,
  6. M Engel6,
  7. P Moroni-Zentgraf6,
  8. A Unseld7,
  9. ED Bateman8
  1. 1Pulmonary Department and Adult Cystic Fibrosis Center, Université Paris Descartes, Sorbonne Paris Cité, Cochin Hospital, AP-HP Paris, Paris, France
  2. 2Pulmonary Department, Mainz University Hospital, Mainz, Germany
  3. 3Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri, USA
  4. 4University of Groningen, Department of Pulmonary Medicine, University Medical Center Groningen, Groningen, The Netherlands
  5. 5Respiratory Pathophysiology and Rehabilitation Unit, University of Pisa, Pisa, Italy
  6. 6TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim Am Rhein, Germany
  7. 7Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an Der Riss, Germany
  8. 8Department of Medicine, University of Cape Town, Cape Town, South Africa

Abstract

Background A high proportion of patients with asthma are symptomatic despite at least ICS maintenance therapy. Five trials aimed to evaluate the safety of tiotropium Respimat® compared with placebo Respimat®, each as add-on to at least ICS in adult patients with symptomatic asthma.

Methods Five Phase III and one Phase II randomised, double-blind, placebo-controlled, parallel-group trials. PrimoTinA-asthma® (48 weeks): tiotropium Respimat® 5 µg add-on to ICS + LABA (≥800 µg budesonide or equivalent); MezzoTinA-asthma® (24 weeks): tiotropium Respimat® 5 µg or 2.5 µg add-on to ICS (400–800 µg budesonide or equivalent); GraziaTinA-asthma® (12 weeks): tiotropium Respimat® 5 µg or 2.5 µg add-on to ICS (200–400 µg budesonide or equivalent); Study 342 (16 weeks): tiotropium Respimat® 5 µg add-on to ICS (400–800 µg budesonide or equivalent). Pooled safety data are presented.

Results 1929 patients received tiotropium Respimat® (PrimoTinA-asthma®, n = 456; MezzoTinA-asthma®, n = 1036; GraziaTinA-asthma®, n = 309; Study 342, n = 128). Frequency of AEs in >2% of patients was comparable in the tiotropium Respimat® 5 µg, tiotropium Respimat® 2.5 µg and placebo Respimat® groups (Table 1). No deaths occurred. 110 (5.7%) and 55 (4.4%) patients receiving tiotropium Respimat® and placebo Respimat®, respectively, reported drug-related AEs (cardiac AEs were rare: tiotropium Respimat®, 7 [0.4%]; placebo Respimat®, 3 [0.2%]). One drug-related serious AE (asthma) was reported with tiotropium Respimat®.

View this table:
Abstract P149 Table 1

Frequency of AEs occurring in >2% of patients

Conclusion Once-daily tiotropium Respimat® add-on to at least ICS maintenance therapy in adult patients demonstrates a safety profile comparable with that of placebo and is well tolerated across severities of symptomatic asthma.

https://doi.org/10.1136/thoraxjnl-2015-207770.286

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