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Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat® inhaler in patients with COPD

René Aalbers, M. Reza Maleki-Yazdi, Alan Hamilton, Stella Waitere-Wijker, Anna Pivovarova, Olaf Schmidt, Leif Bjermer
European Respiratory Journal 2012 40: P2882; DOI:
René Aalbers
1Department of Pulmonary Disease, Martini Hospital, Van Swietenplein 1, Groningen, Netherlands
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M. Reza Maleki-Yazdi
2Division of Respiratory Medicine, Women's College Hospital, University of Toronto, ON, Canada
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Alan Hamilton
3Boehringer Ingelheim, Burlington, Ontario, Canada
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Stella Waitere-Wijker
4Boehringer Ingelheim bv, Comeniusstraat 6, Alkmaar, Netherlands
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Anna Pivovarova
5Boehringer Ingelheim, Pharma GmbH and Co. KG, Biberach, Germany
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Olaf Schmidt
6Lungen- und Bronchialheilkunde, Emil-Schüller-Straße 29, Koblenz, Germany
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Leif Bjermer
7Department of Respiratory Medicine and Allergology, Skåne University Hospital, Lund, Sweden
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Abstract

Background: The novel long-acting β2-agonist olodaterol (O) and long-acting muscarinic antagonist tiotropium (T) have a duration of action of at least 24 h in clinical studies. Dual administration may provide improved bronchodilation with convenient once-daily dosing.

Objective: To determine the optimum once-daily combination of T+O delivered via the Respimat® inhaler in patients with COPD.

Methods: In a randomised, double-blind, 4-period, incomplete crossover study, patients with post-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥30% and <80% of predicted normal received combinations of T and O, with both agents delivered via separate Respimat® inhalers, as well as O monotherapy, once daily for 4 weeks (NCT 01040403). The primary end point was trough FEV1 response (L) at the end of week 4.

Results: In total, 232 COPD patients (133 male; 99 female) received treatment. FEV1 responses (trough and up to 6 h post-dose) for O 5 and 10 μg monotherapy were similar. For all doses of T, FEV1 responses were significantly increased when added to O 5 and 10 μg. Dose ordering for T when added to O was evident. No safety or tolerability concerns were identified.

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Conclusions: Addition of T to O resulted in significant improvements in FEV1 versus O alone. These data support further investigation of T 2.5 and 5 μg combined with O 5 μg in the Phase III T+O clinical trial programme.

  • Bronchodilators
  • COPD - management
  • © 2012 ERS
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Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat® inhaler in patients with COPD
René Aalbers, M. Reza Maleki-Yazdi, Alan Hamilton, Stella Waitere-Wijker, Anna Pivovarova, Olaf Schmidt, Leif Bjermer
European Respiratory Journal Sep 2012, 40 (Suppl 56) P2882;

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Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat® inhaler in patients with COPD
René Aalbers, M. Reza Maleki-Yazdi, Alan Hamilton, Stella Waitere-Wijker, Anna Pivovarova, Olaf Schmidt, Leif Bjermer
European Respiratory Journal Sep 2012, 40 (Suppl 56) P2882;
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