Gillissen Adrian, Marseille Andrea, Skowasch Dirk, Ritz John, Mattiucci-Guehlke Muriel, Pabst Stefan, Greulich Timm, Koczulla Rembert
Medizinische Klinik III, Dept of Internal and Pulmonary Medicine, Klinikum am Steinenberg/Ermstalklinik, Reutlingen, Germany.
HP Country Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
ERJ Open Res. 2021 Sep 6;7(3). doi: 10.1183/23120541.00004-2021. eCollection 2021 Jul.
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 Respimat in routine clinical practice had clinically relevant improvements in health and functional status compared with baseline.
慢性阻塞性肺疾病（COPD）患者的身体活动通常会减少，这会损害健康状况。真实世界的数据可以提供有关接受噻托溴铵/奥达特罗治疗的COPD患者健康和功能状况的有价值信息。AERIAL（ClinicalTrials.gov NCT03165045）是一项在德国进行的非干预性研究，研究对象是在真实世界条件下接受噻托溴铵/奥达特罗治疗约6周的COPD患者。主要终点是临床COPD问卷（CCQ）评分降低≥0.4分的患者比例。CCQ-4子域用于评估功能状态，医生整体评估（PGE）量表用于评估患者的总体状况。对安全性以及患者满意度和继续治疗的意愿进行了评估。在1351名筛查患者中，1322名接受了治疗，1140名组成了完整分析集。达到了主要终点：66.3%的患者CCQ总分降低≥0.4分（平均±标准差降低0.78±0.95）。CCQ症状和功能状态子域的平均±标准差降低分别为0.84±1.06和0.75±1.05分。PGE评分有所改善。记录到1例死亡（与治疗无关）和23例药物相关不良事件，最常见的是恶心和眩晕。超过85%的患者对噻托溴铵/奥达特罗总体以及对Respimat装置在吸入和操作方面均感到满意/非常满意。大多数患者（95.2%）表示愿意继续治疗。与基线相比，在常规临床实践中接受噻托溴铵/奥达特罗Respimat治疗的COPD患者在健康和功能状态方面有临床相关改善。
