Respiratory Medicine Department, University of Ioannina School of Medicine, Ioannina, Greece.
5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, Greece.
Clin Respir J. 2024 Jul;18(7):e13803. doi: 10.1111/crj.13803.
Chronic obstructive pulmonary disease (COPD) is a heterogeneous progressive lung condition characterized by long-term respiratory symptoms and airflow limitation. Appropriate bronchodilation is the cornerstone of COPD treatment, leading to better health status as well as benefits in prognosis and mortality.
In the current open, noninterventional, observational study, 716 patients diagnosed with COPD of variable severity were administered a fixed-dose combination (FDC) of fluticasone propionate and salmeterol (500 + 50 mcg) through the Elpenhaler® device. The patients' adherence to treatment (based on the MMAS-8 [8-item Morisky Medication Adherence Scale]) and health status (based on the CCQ [Clinical COPD Questionnaire]) were assessed at the beginning of the study and at the end of the 3-month follow-up period.
The mean ± SD MMAS-8 score at 1 and 3 months was 6.12 ± 1.89 and 6.45 ± 1.80, respectively, indicating medium adherence overall; however, there was a statistically significant increase of 0.33 units in the MMAS-8 score at the end of the follow-up (paired t-test p < 0.0001), suggestive of an improvement in adherence throughout the study. Higher adherence was associated with better health status at baseline, which further improved by the end of the follow-up. Moreover, we observed a statistically significant decrease of 1.07 points (p < 0.0001) in the mean CCQ total score from the baseline (CCQ score = 2.2 ± 1.00) until the end of the study follow-up (CCQ score = 1.13 ± 0.67). Similar conclusions were also drawn in the mean domain scores regarding symptoms (score equal to 1.36 ± 0.72, decrease by 1.18) as well as functional and mental state (scores equal to 0.86 ± 0.73 and 1.20 ± 0.88, decrease by 1.04 and 1.00, respectively, p < 0.0001). Similarly, when patients were stratified into subgroups with and without comorbidities, the former group showed an increase of 7% in the patients with medium to high adherence during the course of the study. In the same patient subgroup, there was a notable decrease in CCQ score by 1.18 points (p < 0.0001) during the study.
The administration of FDC of fluticasone propionate and salmeterol, (500 + 50 mcg) via the Elpenhaler® device for COPD, resulted in a well-maintained or slight increase in treatment adherence and a subsequent benefit in health status, which further persisted after 3 months of treatment.
慢性阻塞性肺疾病（COPD）是一种异质性的进行性肺部疾病，其特征为长期的呼吸道症状和气流受限。适当的支气管扩张是 COPD 治疗的基石，这可改善健康状况并改善预后和死亡率。
在目前这项开放、非干预性、观察性研究中，通过 Elpenhaler®装置给 716 例轻重度不同的 COPD 患者使用丙酸氟替卡松/沙美特罗固定剂量复方制剂（FDC）（500+50μg）。在研究开始和 3 个月随访结束时，根据 MMAS-8（8 项 Morisky 用药依从性量表）评估患者的治疗依从性（基于 MMAS-8）和健康状况（基于 CCQ [临床 COPD 问卷]）。
在 1 个月和 3 个月时，平均 MMAS-8 评分分别为 6.12±1.89 和 6.45±1.80，总体上表明中等依从性；然而，在随访结束时 MMAS-8 评分增加了 0.33 个单位（配对 t 检验 p<0.0001），提示整个研究期间依从性有所提高。较高的依从性与基线时的健康状况较好相关，在随访结束时进一步得到改善。此外，我们观察到，从基线（CCQ 评分=2.2±1.00）到研究随访结束时（CCQ 评分=1.13±0.67），CCQ 总分平均下降了 1.07 分（p<0.0001）。在症状（评分等于 1.36±0.72，下降 1.18）以及功能和精神状态（评分分别为 0.86±0.73 和 1.20±0.88，下降 1.04 和 1.00，p<0.0001）的平均领域评分中也得出了类似的结论。同样，当将患者分为有或无合并症的亚组时，在研究过程中，中高度依从性患者的比例增加了 7%。在同一患者亚组中，在研究期间 CCQ 评分显著下降 1.18 分（p<0.0001）。
通过 Elpenhaler®装置给予丙酸氟替卡松/沙美特罗 FDC（500+50μg）治疗 COPD 可保持或略微提高治疗依从性，并随后改善健康状况，且在治疗 3 个月后仍持续获益。
