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An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive
Epaminondas Kosmas1, Iraklis Titopoulos2, Georgios Patentalakis3
1Metropolitan Hospital, Athens, Greece.
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.
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