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P258 The 24-hour Lung Function Profile Of Once-daily Tiotropium And Olodaterol Fixed-dose Combination Compared With Placebo And Monotherapies In Chronic Obstructive Pulmonary Disease
  1. E Derom1,
  2. J Westerman2,
  3. L Grönke3,
  4. A Hamilton4,
  5. C Li5,
  6. KM Beeh6
  1. 1Ghent University Hospital, Ghent, Belgium
  2. 2Pulmonary and Sleep Associates of Jasper, Jasper, Alabama, USA
  3. 3Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany
  4. 4Boehringer Ingelheim, Burlington, Ontario, Canada
  5. 5Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA
  6. 6Insaf GmbH Institut Für Atemwegsforschung, Wiesbaden, Germany

Abstract

Introduction Tiotropium (T), a once-daily long-acting muscarinic antagonist, is a well-established first-line maintenance treatment in chronic obstructive pulmonary disease (COPD). Olodaterol (O) is a once-daily long-acting β2-agonist, recently approved in several EU countries. This study investigated the 24-hour bronchodilator profile of once-daily fixed-dose combinations (FDCs) of T and O delivered via the Respimat® Soft Mist™ inhaler in patients with Global initiative for chronic Obstructive Lung Disease 2–4 COPD.

Methods This double-blind, placebo-controlled, Phase III, incomplete crossover study randomised 219 patients to receive four of the following treatments for 6 weeks (with a 3-week washout period in between): placebo, O 5 µg, T 2.5 µg, T 5 µg, T+O FDC 2.5/5 µg, T+O FDC 5/5 µg. The primary end point was forced expiratory volume in 1 second (FEV1) area under the curve from 0–24 h (AUC0–24) after 6 weeks. Secondary end points included additional spirometric parameters over 24 h and body plethysmography parameters in a sub-set of patients (2:30 and 22:30 h post-dose).

Results The 24-hour time profiles for both FDCs were similar, with clear, consistent increases in FEV1 compared to placebo and monotherapies. For FEV1 AUC0–24, both FDCs were significantly superior to placebo (T+O 5/5 µg: 0.280 L, p < 0.0001; T+O 2.5/5 µg: 0.277 L, p < 0.0001) and monotherapies (T+O 5/5 µg: 0.110–0.127 L, p < 0.0001; T+O 2.5/5 µg: 0.107–0.124 L, p < 0.0001). There were significantly greater increases in trough FEV1 with both FDCs compared to placebo (0.201–0.207 L, p < 0.0001) and monotherapies (T+O 5/5 µg: 0.079–0.107 L, p < 0.0001; T+O 2.5/5 µg: 0.073–0.101 L, p < 0.0001). In the body plethysmography sub-study, both FDC doses separated from placebo and monotherapies in functional residual capacity (p < 0.001) and residual volume (p < 0.0001). Both FDCs were well tolerated; overall incidence of adverse events ranged between 36.0% (T+O 2.5/5 µg) and 46.4% (placebo).

Conclusions Both FDC 24-hour time profiles showed clear and consistent increases in FEV1 compared to placebo and monotherapies, with a similar tolerability profile to T.

Abstract P258 Figure 1

Adjusted mean Fev1 over 24 h post dose after 6 weeks of treatment (full analysis set)

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