Respiratory Medicine Department, University Hospital of Ioannina, Ioannina, Greece.
5th Respiratory Medicine Department, General Hospital for Chest Diseases of Athens "SOTIRIA", Athens, Greece.
Int J Chron Obstruct Pulmon Dis. 2022 Sep 1;17:2027-2041. doi: 10.2147/COPD.S367553. eCollection 2022.
The rationale of this study was to investigate the prevalence of daily and night symptoms and quality of sleep in Greek COPD patients as a means to evaluate their response to treatment with the fixed dose combination of aclidinium/formoterol (administered through the Genuair device).
This study was a multicenter, nationwide, non-interventional, observational study in 2105 patients suffering from COPD, who have recently started treatment with aclidinium/formoterol. Patients were attending to two visits, one baseline and a final visit, 3 months later. Different variables have been collected on either the baseline or the final visit or both: demographics, vital sign measurements, COPD-related medical history parameters, comorbidities, COPD assessment test (CAT), COPD severity based on spirometry measurements, COPD stage based on the ABCD assessment approach proposed by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD), COPD treatment report, and severity of early-morning, daytime and night-time COPD-related symptoms. Reasons for prescribing aclidinium/formoterol, satisfaction of patients to the treatment, as well as their compliance have also been recorded.
After 3 months on aclidinium/formoterol, 50.1% of the patients experienced an improvement in their early-morning symptoms. Furthermore, 49.9% of them experienced an improvement in their daily symptoms, 44.9% improved their night-time symptoms and 43.2% reduced the frequency of overnight sleep disruptions due to COPD symptoms. These favorable outcomes apply mainly to GOLD Groups B-D. Treatment with aclidinium/formoterol improved on average the pre-bronchodilation FEV1% pred by 3.18%, the post-bronchodilation FEV1% pred by 2.78% and reduced CAT score by 5.22 points. Satisfaction with using aclidinium/formoterol across patients was high, as well as compliance to therapy.
Aclidinium/formoterol provided significant benefits on the quality of life of COPD patients by reducing the morning, daytime and the night-time symptoms and symptom burden in GOLD Groups B-D, and activity impairment under real-life conditions in all GOLD ABCD groups.
本研究的原理是调查希腊 COPD 患者的日常和夜间症状以及睡眠质量，以评估他们对使用固定剂量的阿地氯铵/福莫特罗（通过 Genuair 装置给药）治疗的反应。
这是一项多中心、全国性、非干预性、观察性研究，共纳入 2105 例最近开始使用阿地氯铵/福莫特罗治疗的 COPD 患者。患者在基线和 3 个月后的最终访视时接受了两次访视。在基线或最终访视或两者时收集了不同的变量：人口统计学、生命体征测量、COPD 相关病史参数、合并症、COPD 评估测试（CAT）、根据肺量计测量的 COPD 严重程度、根据 2019 年全球慢性阻塞性肺疾病倡议（GOLD）提出的 ABCD 评估方法的 COPD 阶段、COPD 治疗报告以及清晨、日间和夜间 COPD 相关症状的严重程度。还记录了开具阿地氯铵/福莫特罗的原因、患者对治疗的满意度以及他们的依从性。
在使用阿地氯铵/福莫特罗治疗 3 个月后，50.1%的患者清晨症状得到改善。此外，49.9%的患者日常症状得到改善，44.9%的患者夜间症状得到改善，43.2%的患者因 COPD 症状导致夜间睡眠中断的频率减少。这些有利结果主要适用于 GOLD 组 B-D。阿地氯铵/福莫特罗治疗平均改善预支气管扩张 FEV1%预测值 3.18%，支气管扩张后 FEV1%预测值 2.78%，并降低 CAT 评分 5.22 分。患者对使用阿地氯铵/福莫特罗的满意度较高，治疗依从性也较好。
阿地氯铵/福莫特罗通过减少 GOLD 组 B-D 的清晨、日间和夜间症状以及症状负担，并在所有 GOLD ABCD 组中减轻现实生活中的活动障碍，显著改善了 COPD 患者的生活质量。
