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P256 Safety Of Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat In Chronic Obstructive Pulmonary Disease In Two 1-year Studies
  1. R Buhl1,
  2. R Abrahams2,
  3. L Bjermer3,
  4. E Derom4,
  5. M Fležar5,
  6. J Hébert6,
  7. A Veale7,
  8. L Grönke8,
  9. A Hamilton9,
  10. K Tetzlaff8,
  11. L Korducki10,
  12. H Huisman11,
  13. S Waitere-Wijker11,
  14. L McGarvey12
  1. 1Pulmonary Department, Mainz University Hospital, Mainz, Germany
  2. 2Morgantown Pulmonary Associates, Morgantown, West Virginia, USA
  3. 3Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden
  4. 4Ghent University Hospital, Ghent, Belgium
  5. 5Klinika Golnik, Golnik, Slovenia
  6. 6Centre de Recherche Appliquée en Allergie de Québec (CRAAQ), Québec, Canada
  7. 7Department of Respiratory Medicine, The Queen Elizabeth Hospital, Adelaide, Australia
  8. 8Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany
  9. 9Boehringer Ingelheim, Burlington, Ontario, Canada
  10. 10Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA
  11. 11Boehringer Ingelheim B. V., Alkmaar, The Netherlands
  12. 12Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, UK

Abstract

Introduction The fixed-dose combination (FDC) of tiotropium (T), a once-daily long-acting muscarinic antagonist, and olodaterol (O), a once-daily long-acting β2-agonist, is currently being evaluated in chronic obstructive pulmonary disease (COPD).

Two 52-week, Phase III replicate pivotal studies were conducted to assess the efficacy and safety of FDCs of T and O (T+O) delivered via Respimat® Soft Mist™ inhaler in patients (pts) with GOLD Stage 2–4 COPD. Pooled safety data from the two studies are presented here.

Methods These were double-blind, randomised, parallel-group studies with 5 arms: O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg, T+O 5/5 µg. Key inclusion criteria were: age ≥40 years, diagnosis of COPD, smoking history >10 pack-years. Pts with a history of asthma or significant disease other than COPD were excluded. Adverse events (AEs) were reported throughout the studies.

Results A total of 5162 pts were randomised and treated. In general, AEs, serious AEs and fatal AEs were balanced across treatment groups. In particular, frequencies of AEs in the cardiac disorders System Organ Class (SOC) and respiratory disorders SOC were similar.

Conclusions T+O FDCs were safe and well tolerated. In comparison to the individual components, there was no notable increase in AEs with T+O FDCs.

Abstract P256 Table 1

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