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

Abstract

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 Ò 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 Ò for approximately 6 weeks. The primary endpoint was ''therapeutic success'' defined as a C 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 Ò device (assessed by the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ)) at week 6 and treatment continuation with tiotropium/olodaterol Respimat Ò after the study. Results: After approximately 6 weeks of treatment with tiotropium/olodaterol Respimat Ò , 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 Ò device. Among patients previously using the Handi-Haler Ò device (n = 254), 85.4% expressed a preference for Respimat Ò over 6.7% for Handi-Haler Ò . Most patients (95.7%) were willing to continue treatment with tiotropium/olodaterol Respimat Ò after the study. Conclusions: Treatment with tiotropium/olodaterol Respimat Ò led to an improved health status in Greek COPD patients. Most patients also expressed a preference for the Respimat Ò