Gálffy Gabriella, Szilasi Maria, Tamási Lilla
Pulmonary Hospital Törökbálint, Törökbálint, Hungary.
Faculty of Medicine, Department of Pulmonology, University of Debrecen, Debrecen, Hungary.
Pulm Ther. 2019 Dec;5(2):165-177. doi: 10.1007/s41030-019-0097-7. Epub 2019 Jul 29.
Persistent symptoms, poor disease control, and reduced quality of life (QoL) are common in patients with asthma and chronic obstructive pulmonary disease (COPD). Current therapies are only partially effective and inhaler misuse contributes to insufficient disease control and poor outcomes. This real-world study aimed to evaluate the effectiveness of budesonide/formoterol fumarate (B/F) Easyhaler in everyday clinical practice in Hungary.
Post hoc, subgroup analyses of this 12-week, real-world, multicenter, open-label study were conducted in adults diagnosed with asthma or COPD. Endpoints included the change in patient-reported outcome measures; i.e., symptoms and disease control measured by Asthma Control Test or COPD Assessment Test and health-related (HR)QoL measured by mini-Asthma Quality of Life Questionnaire or modified Medical Research Council dyspnea scale. Changes in lung function and patient satisfaction with B/F Easyhaler versus their previous inhaler were also evaluated. Results were stratified by the inhaler device used at visit 1 (baseline, when patients switched device); comparisons were made with B/F Easyhaler use after 12 weeks, assessed at visit 3.
In total, 398 and 563 patients with asthma and COPD, respectively, were analyzed. Significant improvements (p < 0.0001) in symptoms and disease control, HRQoL, and lung function were reported 12 weeks after switching treatment to B/F Easyhaler from the most commonly used devices (≥ 10% of patients). Significant increases in patient satisfaction were also reported versus comparators.
Patients with asthma or COPD who switched to B/F Easyhaler from their previous inhaler due to lack of disease control achieved significant improvements in symptoms and disease control, HRQoL, and lung function within 12 weeks of real-world use with significant increase in patient satisfaction also observed. Such comparative information may reassure clinicians and patients that may be viewed as an appropriate and potentially beneficial treatment option.
OGYÉI/13942-5/2016 (National Pharmaceutical Institute of Pharmacy and Nutrition of Hungary).
Orion Corporation, Orion Pharma. Plain language summary available for this article.
哮喘和慢性阻塞性肺疾病（COPD）患者常出现持续症状、疾病控制不佳及生活质量（QoL）下降的情况。目前的治疗方法仅部分有效，吸入器使用不当会导致疾病控制不足和预后不良。这项真实世界研究旨在评估布地奈德/富马酸福莫特罗（B/F）易纳器在匈牙利日常临床实践中的有效性。
对这项为期12周的真实世界、多中心、开放标签研究进行事后亚组分析，研究对象为被诊断患有哮喘或COPD的成年人。研究终点包括患者报告的结局指标的变化；即通过哮喘控制测试或慢性阻塞性肺疾病评估测试测量的症状和疾病控制情况，以及通过小型哮喘生活质量问卷或改良的医学研究委员会呼吸困难量表测量的健康相关（HR）生活质量。还评估了肺功能的变化以及患者对B/F易纳器与之前使用的吸入器的满意度。结果根据首次就诊（基线，即患者更换吸入器时）使用的吸入器装置进行分层；与第3次就诊时评估的12周后使用B/F易纳器的情况进行比较。
分别对398例哮喘患者和563例COPD患者进行了分析。从最常用的装置（≥10%的患者）改用B/F易纳器治疗12周后，症状和疾病控制、健康相关生活质量以及肺功能均有显著改善（p < 0.0001）。与对照相比，患者满意度也显著提高。
因疾病控制不佳而从之前的吸入器改用B/F易纳器的哮喘或COPD患者，在实际使用12周内，症状和疾病控制、健康相关生活质量以及肺功能均有显著改善，患者满意度也显著提高。此类比较信息可能会让临床医生和患者放心，这可能被视为一种合适且潜在有益的治疗选择。
OGYÉI/13942 - 5/2016（匈牙利国家药学与营养药物研究所）。
奥立安集团，奥立安制药公司。本文提供了通俗易懂的摘要。
