The effect of tiotropium/olodaterol versus fluticasone propionate/salmeterol on left ventricular filling and lung hyperinflation in patients with COPD.

This exploratory, randomised, double-blind, double-dummy, multicentre, cross-over study explored the effect of 6 weeks of treatment with tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S) on left ventricular filling in patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5%. Overall, 76 patients were randomised across nine sites. Treatment with T/O or F/S increased left ventricular end-diastolic volume index from baseline (adjusted mean change: T/O: 2.317 mL/m ² , F/S: 2.855 mL/m ² ), with no statistically significant difference between treatments. However, T/O resulted in a significantly greater reduction in lung hyperinflation versus F/S (FRC plethysmography absolute change from baseline: F/S: -0.329 L, T/O: -0.581 L).
Competing Interests: Ethics approval and patient consent: All studies included in this analysis were performed in accordance with the provisions of the Declaration of Helsinki (1996 version), the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice, applicable regulatory requirements and Boehringer Ingelheim Standard Operating Procedures. All patients provided written informed consent. This article does not report individual patient data; all data presented here are anonymised. The clinical trial protocols and the informed consent and patient information forms were reviewed and received approval/favourable opinion from a constituted local Institutional Review Board or an Independent Ethics Committee at each centre prior to the start of the study. This study was approved by Ethikkomission Medizinische Heidelberg under ID number AFmu-559/2016.
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