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).
- Herth, F.
- Hohlfeld, J. M.
- Haas, J.
- de la Hoz, A.
- Jin, X.
- Kreitner, K. F.
- Vogelmeier, C.
- Vogel-Claussen, J.
- Watz, H.
Keywords
- COPD pharmacology
- inhaler devices
- respiratory measurement
- 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.