ABSTRACT
OBJECTIVE: We aim to determine the effect of a fixed-dose combination (FDC) of tiotropium/olodaterol on Physical activity (PA) in patients with chronic obstructive pulmonary disease (COPD) in a real world setting. METHODS: COPD patients were prospectively enrolled to evaluate the effect of a FDC of tiotropium/olodaterol inhaler therapy via the Respimat® Soft Mist™ inhaler (SMI) on the physical functioning scale (PF-10), and the general condition of the patient as assessed by the physician (Physician's Global Evaluation, PGE), and the patient's satisfaction after 6 weeks of treatment. The primary end-point was the percentage of patients with therapeutic success at 6th week follow-up, defined as a ≥10-points increase in the standardised PF-10 score from baseline. RESULTS: A total of 257 patients from 57 sites were enrolled, and 234 completed the follow up. After 6 weeks of treatment, 155 out of 234 patients (66.2%) showed therapeutic success in the physical functioning score, coupled with significant improvement in PGE score: 78 (33.3%) patients with good/excellent PGE score at baseline, increasing to 172 (73.5%) at 6th week (p<0.0001). The patient's satisfaction was excellent: 77.2% reporting to be satisfied/very satisfied with the treatment, 79.9% with inhaling and 79.0% with the handling of SMI device. 1.6% of patients reported an investigator-defined drug-related adverse event. CONCLUSION: Treatment of COPD patients with a FDC of tiotropium/olodaterol SMI for 6 weeks resulted in significant improvements in the patients' condition as assessed by patients and physicians, with no new safety findings.
