ABSTRACT
INTRODUCTION: Clinical studies have shown significant improvements in exercise capacity in patients with chronic obstructive pulmonary disease (COPD) who are treated with a tiotropium/olodaterol fixed-dose combination (FDC). However, the effects of this treatment, which is administered in a single device, on physical functioning in a real-life setting of patients with COPD had not been fully determined. METHODS: An open-label, observational study was conducted in 309 patients with COPD from 29 sites across Italy who received tiotropium/olodaterol FDC for 6 weeks. Physical functioning was evaluated using the Physical Functioning Questionnaire (PF-10). The primary endpoint was the proportion of patients with therapeutic success, defined as a ten-point increase in the PF-10 score from the baseline visit. Secondary endpoints were absolute changes in PF-10 score from baseline visit, the patient's general condition assessed by the Physician's Global Evaluation (PGE) score, and patient satisfaction with treatment, inhaling and handling of the device. RESULTS: According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) multimodality assessment, most patients were allocated to groups B (44.4%) and D (24.5%). Comorbidities were present in 73.9% of the patients. The primary endpoint was reached in more than half of the patients (52.5%), especially in groups B and D of GOLD. Patients' satisfaction with treatment, inhaling and handling of device was high, with a range of more than 86% to more than 89%, and very high in both groups B and D. The rates of drug-related adverse events were very low. CONCLUSIONS: This real-life study showed that the tiotropium/olodaterol FDC treatment delivered via the Respimat device improves physical functioning and general patients' condition and is associated with a high degree of satisfaction and very low rates of drug-related adverse events, regardless of the group they belong to and their comorbidities. CLINICAL TRIAL ID: NCT03003494.
