Rationale Chronic bronchitis and emphysema are common features of chronic obstructive pulmonary disease (COPD), and are associated with adverse symptoms and poor health-related quality of life. The efficacy and safety of the combination of tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist, has previously been established in COPD. This post hoc analysis of data from two Phase III studies was conducted to assess the effects of this combination on lung function, symptoms and health-related quality of life in patients with COPD with chronic bronchitis and/or emphysema.
Methods In two replicate, double-blind, parallel-group, placebo-controlled trials (OTEMTO® 1 and 2), patients with COPD (GOLD 2–3) were randomised to receive T/O 5/5 µg, T/O 2.5/5 µg, T 5 µg or placebo (P) for 12 weeks via Respimat® inhaler.1 Patients were classified as having chronic bronchitis, emphysema or both based on the investigator’s clinical judgement. Lung-function testing was performed during the studies and forced expiratory volume in 1 second (FEV1) area under the curve from 0–3 hours (AUC0–3) and trough FEV1 responses (i.e., change from baseline) calculated. Patients also completed the St George’s Respiratory Questionnaire (SGRQ) and the Mahler Transition Dyspnoea Index (TDI). Comparisons between T/O 5/5 µg, T 5 µg and P at Week 12 are reported here.
Results The numbers of patients included in the analysis were as follows: bronchitis, 506; emphysema, 476; both bronchitis and emphysema, 206. The baseline characteristics of these three groups were generally comparable. After 12 weeks of treatment, there were significant improvements in FEV1 AUC0–3 and trough FEV1 in all groups, with similar improvements across the groups. Significant improvements in SGRQ and TDI occurred in all groups at Week 12 and, again, these seemed to be similar (Table).
Conclusions T/O 5/5 µg resulted in significant improvements in lung function, dyspnoea and health-related quality of life in patients with moderate to severe COPD with bronchitis, emphysema or both bronchitis and emphysema.
Singh D, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med 2010;109(10):1312–9.
Funding Boehringer Ingelheim.
Please refer to page A271 for declarations of interest in relation to abstract P55.
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