An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive Pulmonary Disease (COPD) During Therapy with Spiolto Respimat in Everyday Clinical Practice: The Greek ELLACTO Study.

Introduction: Patients with chronic obstructive pulmonary disease (COPD) often report deteriorated functional status and poor health-related quality of life, both core aspects of their overall health status. The study objective was to assess tiotropium/olodaterol Respimat effects on health and functional status of COPD patients requiring long-acting dual bronchodilation treatment in the real world.

Methods: ELLACTO was an open-label, observational, prospective study conducted in Greece, measuring changes on health and functional status of COPD patients treated with a fixed dose of tiotropium/olodaterol Respimat for approximately 6 weeks. The primary endpoint was "therapeutic success" defined as a ≥ 0.4-point decrease in the Clinical COPD Questionnaire (CCQ) score at week 6. Secondary endpoints included absolute changes in the CCQ and the functional subscale CCQ-4 at week 6, patient general condition measured by Physician's Global Evaluation (PGE) score at baseline and week 6, patient satisfaction and preference with Respimat device (assessed by the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ)) at week 6 and treatment continuation with tiotropium/olodaterol Respimat after the study.

Results: After approximately 6 weeks of treatment with tiotropium/olodaterol Respimat, therapeutic success was achieved by 64.3% of 1332 patients included in the final analysis [95% confidence interval [CI] 62-67]. Mean [standard deviation (SD)] absolute changes in CCQ and CCQ-4 scores at week 6 were - 0.63 (0.635) and - 0.59 (0.714) points, respectively. Patient general condition improved and more than 77.4% of patients were satisfied or very satisfied with the use of the Respimat device. Among patients previously using the HandiHaler device (n = 254), 85.4% expressed a preference for Respimat over 6.7% for HandiHaler. Most patients (95.7%) were willing to continue treatment with tiotropium/olodaterol Respimat after the study.

Conclusions: Treatment with tiotropium/olodaterol Respimat led to an improved health status in Greek COPD patients. Most patients also expressed a preference for the Respimat device and willingness to continue treatment with it.

Trial Registration: ClinicalTrials.gov NCT03419962.