Respiratory Medicine Department, University of Ioannina School of Medicine, Ioannina, Greece.
1St Department of Respiratory Medicine, Medical School, National and Kapodistrian University of Athens and "Sotiria" Chest Disease Hospital, 11527, Athens, Greece.
BMC Pulm Med. 2022 Jun 27;22(1):254. doi: 10.1186/s12890-022-02049-0.
Asthma is a chronic inflammatory disease of the airways that causes recurring episodes of wheezing, breathlessness, chest tightness and coughing. Inhaled drugs on a daily basis are the cornerstone of asthma treatment, therefore, patient adherence is very important.
We performed a multicenter, open, non-interventional, observational, prospective study of 716 adult patients diagnosed with asthma receiving FDC (Fixed-dose combination) budesonide/formoterol via the Elpenhaler device. We assessed the adherence to treatment at 3 and 6 months (based on the MMAS-8: 8-item Morisky Medication Adherence Scale), the quality of life and change in forced expiratory volume in 1 s (FEV1) from baseline to follow-up.
Approximately 80% of the patients showed medium to high adherence throughout the study. The mean (SD) MMAS-8 score at 6 months was 6.85 (1.54) and we observed a statistically significant shift of patients from the low adherence group to the high adherence group at 6 months. Moreover, after 6 months of treatment with FDC budesonide/formoterol, we observed an increase in the patients' quality of life that as expressed by a change 2.01 (95%CI 1.93-2.10) units in Mini AQLQ (p < 0.0001) that was more pronounced in the high adherence group. The same trend was also observed in terms of spirometry (mean FEV1 2.58 L (0.85) at the end of the study, increased by 220 mL from baseline) with a higher improvement in the medium and high adherence groups.
Treatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with improvement in asthma-related quality of life and lung function over 6 months that were more prominent in patients with higher adherence.
2017-HAL-EL-74 (ClinicalTrials.gov Identifier: NCT03300076).
哮喘是一种气道慢性炎症性疾病，会导致反复发作的喘息、呼吸困难、胸闷和咳嗽。每天吸入药物是哮喘治疗的基石，因此患者的依从性非常重要。
我们对 716 名诊断为哮喘的成年患者进行了一项多中心、开放、非干预性、观察性、前瞻性研究，这些患者使用 Elpenhaler 装置接受布地奈德/福莫特罗固定剂量复方制剂（FDC）治疗。我们在 3 个月和 6 个月时评估了治疗的依从性（基于 MMAS-8：8 项 Morisky 用药依从性量表）、生活质量以及从基线到随访时用力呼气量（FEV1）的变化。
大约 80%的患者在整个研究过程中表现出中高度的依从性。6 个月时的平均（SD）MMAS-8 评分为 6.85（1.54），我们观察到 6 个月时患者从低依从性组向高依从性组的转移具有统计学意义。此外，在接受布地奈德/福莫特罗 FDC 治疗 6 个月后，我们观察到患者的生活质量提高，Mini AQLQ 变化 2.01（95%CI 1.93-2.10）单位（p<0.0001），在高依从性组更为明显。在肺功能方面也观察到了类似的趋势（研究结束时平均 FEV1 为 2.58 L（0.85），与基线相比增加了 220 mL），中高度依从性组的改善更为显著。
使用 Elpenhaler 装置给予布地奈德/福莫特罗 FDC 治疗与 6 个月时哮喘相关生活质量和肺功能的改善相关，在依从性较高的患者中更为显著。
2017-HAL-EL-74（ClinicalTrials.gov 标识符：NCT03300076）。
