Physical Functioning in Patients with Chronic Obstructive Pulmonary Disease Treated with Tiotropium/Olodaterol Respimat in Routine Clinical Practice in Italy

Mauro Carone, Alfio Pennisi, Mariella D'Amato, Alfeo Fiore Donati, Alberto Ricci, Carla Scognamillo, Li Chun, Maria Aliani, Valeria Ronsivalle, Girolamo Pelaia, Mauro Carone, Alfio Pennisi, Mariella D'Amato, Alfeo Fiore Donati, Alberto Ricci, Carla Scognamillo, Li Chun, Maria Aliani, Valeria Ronsivalle, Girolamo Pelaia

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.

Keywords: COPD; Exercise capacity; Fixed-dose combination; Health status; Inhaling device; Long-acting dual bronchodilation; Olodaterol; Patient-reported outcomes; Physical functioning; Tiotropium.

Figures

Fig. 1
Fig. 1
Patient flow chart
Fig. 2
Fig. 2
Physician’s global evaluation (PGE) at visit 1 and visit 2. FAS full analysis set, TS treated set

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