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P296 Effect of tiotropium/olodaterol therapy on copd exacerbations in the tonado® studies
  1. E Derom1,
  2. M Fležar2,
  3. L Grönke3,
  4. F Voß3,
  5. R Buhl4
  1. 1Ghent University Hospital, Ghent, Belgium
  2. 2University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia
  3. 3Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany
  4. 4Pulmonary Department, Mainz University Hospital, Mainz, Germany

Abstract

Rationale The lung-function efficacy, symptomatic benefits and safety of combined tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist, for the treatment of COPD, was established in the year-long TONADO® studies (NCT01431274; NCT01431287). It is unknown if these benefits of T/O translate into a reduction in COPD exacerbation rate.

Methods Two replicate, randomised, double-blind, parallel-group trials assessed T/O 2.5/5 μg and T/O 5/5 μg compared to the monocomponents T 5 μg, T 2.5 μg and O 5 µg (all delivered via Respimat® inhaler) in patients with moderate to very severe COPD. Primary end points included lung function (forced expiratory volume in 1 second [FEV1] area under the curve from 0–3 hours response, trough FEV1 response) and quality of life (SGRQ). Analysis of the number of exacerbations and time to exacerbation was pre-specified using data from the combined TONADO® studies. We present data from the T/O and T treatment arms.

Results 4124 patients were evaluable for the T/O and T treatment arms. Moderate or severe exacerbations occurred in 27.7% of patients with T/O 5/5 μg, 25.8% of patients with T/O 2.5/5 μg, 28.8% with T 5 μg and 29.6% with T 2.5 μg. Severe exacerbations occurred in 5.9% of patients receiving T/O 5/5 μg, 4.5% receiving T/O 2.5/5 μg, 4.5% receiving T 5 μg and 5.2% receiving T 2.5 μg. The treatment comparisons for any exacerbation and moderate/severe exacerbations were generally consistent between the two studies, except for a higher number of severe exacerbations with T/O 5/5 μg in TONADO® 1 only (Table).

Conclusions Although there were fewer exacerbations overall with T/O 2.5/5 µg or 5/5 µg compared to T 2.5 µg or 5 µg, and a numerically longer time to first moderate/severe exacerbation, the TONADO® studies did not show a significant difference in the hazard ratios for time to exacerbation end points. These findings are partially attributable to a higher number of severe exacerbations with T/O 5/5 µg in TONADO® 1. TONADO® was not designed for formal comparison of exacerbations with T/O versus T; however, a study powered to assess this is ongoing.

Funding Boehringer Ingelheim.

Please refer to page A273 for declarations of interest in relation to abstract P296.

Abstract P296 Table 1

Treatment comparisons of time to first COPD exacerbation and first moderate/severe COPD exacerbation

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