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P125 Tiotropium plus olodaterol combination therapy provides lung-function benefits when compared to tiotropium alone, irrespective of prior treatment with a long-acting bronchodilator: post hoc analyses of two 1-year studies
  1. R Buhl1,
  2. R Abrahams2,
  3. L Grönke3,
  4. L Korducki3,
  5. M Fležar4,
  6. GT Ferguson5
  1. 1Pulmonary Department, Mainz University Hospital, Mainz, Germany
  2. 2Morgantown Pulmonary Associates, Morgantown, West Virginia, USA
  3. 3Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
  4. 4Klinika Golnik, Golnik, Slovenia
  5. 5Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan, USA

Abstract

Rationale Tiotropium plus olodaterol (T+O) is a novel once-daily combination of the long-acting muscarinic antagonist (LAMA) tiotropium (T) and the recently approved long-acting β2-agonist (LABA) olodaterol, for use as maintenance treatment in chronic obstructive pulmonary disease (COPD). These post hoc analyses of data from the two pivotal 1-year TONADO studies determined whether treatment with a long-acting bronchodilator (LABD) prior to randomisation affected the lung-function benefits of T+O 5/5 µg (via Respimat®) compared to T 5 µg (via Respimat®).

Methods In the studies, 2124 patients had not received prior LABD treatment (T+O n = 426; T n = 454) and 3038 patients had (T+O n = 603, T n = 579; 60.6% LAMA, 78.8% LABA). Baseline characteristics for all patients and a sub-group with Global initiative for chronic Obstructive Lung Disease (GOLD) 2 lung-function impairment are presented in the Table 1. Forced expiratory volume in 1 s (FEV1) area under the curve from 0–3 h (AUC0–3) response (change from baseline) and trough FEV1 response were primary end points in the studies.

Abstract P125 Table 1

 

Results Comparable responses for both FEV1 AUC0–3 and trough FEV1 were observed in patients previously treated and untreated with LABD (see Table 1). The between-treatment differences (adjusted mean response [SE]; mL) for no prior LABD and prior LABD treatment, respectively, were: 116 (13) and 105 (11) for FEV1 AUC0–3, and 76 (14) and 49 (11) for trough FEV1. In the GOLD 2 subgroup, the between-treatment differences (adjusted mean response [SE]; mL) for no prior LABD and prior LABD treatment, respectively, were: 114 (19) and 123 (17) for FEV1 AUC0–3, and 79 (20) and 61 (18) for trough FEV1.

Conclusions Our analyses demonstrate the robust lung-function efficacy of T+O, compared to T alone, independent of the requirement for, or prior use of, LABD. These findings suggest a benefit of combination therapy over the mono-product as a first-line maintenance treatment.

Funding Boehringer Ingelheim.

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