TY - JOUR T1 - Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL® non-interventional study JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00004-2021 VL - 7 IS - 3 SP - 00004-2021 AU - Adrian Gillissen AU - Andrea Marseille AU - Dirk Skowasch AU - John Ritz AU - Muriel Mattiucci-Guehlke AU - Stefan Pabst AU - Timm Greulich AU - Rembert Koczulla Y1 - 2021/07/01 UR - http://openres.ersjournals.com/content/7/3/00004-2021.abstract N2 - Patients with COPD often have reduced physical activity, which can impair health status. Real-world data can provide valuable information on the health and functional status of patients with COPD treated with tiotropium/olodaterol. AERIAL® (ClinicalTrials.gov NCT03165045) was a German, non-interventional study of patients with COPD receiving treatment with tiotropium/olodaterol under real-world conditions for ∼6 weeks. The primary end-point was the proportion of patients achieving a decrease of ≥0.4 points in Clinical COPD Questionnaire (CCQ) score. The CCQ-4 subdomain was used to assess functional status, and the Physician's Global Evaluation (PGE) scale was used to assess the patients’ general condition. Safety was assessed, as well as patient satisfaction and willingness to continue treatment. Out of 1351 screened patients, 1322 were treated and 1140 comprised the full analysis set. The primary end-point was met: 66.3% of patients achieved a ≥0.4-point decrease in overall CCQ score (mean±sd decrease 0.78±0.95). Mean±sd decreases in CCQ symptoms and functional state subdomains were 0.84±1.06 and 0.75±1.05 points, respectively. PGE scores improved. One fatality (not treatment-related) and 23 drug-related adverse events were recorded, most commonly nausea and vertigo. >85% of patients were satisfied/very satisfied with tiotropium/olodaterol overall and with the Respimat® device, both in terms of inhalation and handling. Most patients (95.2%) expressed willingness to continue treatment. Patients with COPD treated with tiotropium/olodaterol via Respimat® in routine clinical practice had clinically relevant improvements in health and functional status compared with baseline.The AERIAL non-interventional study demonstrated that patients with COPD treated with tiotropium/olodaterol via Respimat in routine clinical practice had high product satisfaction and clinically relevant improvements in health and functional status https://bit.ly/3jf6hIf ER -