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

IntroductionPatients 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.MethodsELLACTO 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.ResultsAfter 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.ConclusionsTreatment 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 registrationClinicalTrials.gov NCT03419962.