{"title":"Evaluating digital adherence support in asthma: the ADITION non-interventional study.","authors":"Holger Woehrle, Jens Driemert, Lukas Jerrentrup, Conrad Schiefer, Gregor Bushart, Inessa Schwab Sauerbeck","doi":"10.1183/23120541.00734-2024","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Poor adherence to asthma maintenance therapy is associated with worse outcomes. A solution could be digital adherence support. This study evaluated asthma control and adherence in patients using mometasone furoate/indacaterol/glycopyrronium (MF/IND/GLY) with a digital support system or using any inhaled corticosteroid/long-acting β<sub>2</sub>-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) combination without support.</p><p><strong>Methods: </strong>This prospective, non-interventional, multicentre, open-label study enrolled adults with asthma in Germany. Prior to inclusion, treatment was initiated with MF/IND/GLY with digital support or with any ICS/LABA/LAMA without digital support. The primary end-point was change in Asthma Control Test (ACT) at 6 months.</p><p><strong>Results: </strong>Of 222 and 203 patients in the MF/IND/GLY plus digital support and ICS/LABA/LAMA groups, 76.1% and 74.9% completed follow-up, respectively. Baseline mean ACT total scores were 17.0 and 14.7, with mean changes from baseline at 6 months of 3.0 and 4.1, respectively; following propensity matching (n=92 per group), mean changes were similar in the two groups, with overlapping 95% confidence intervals (2.9 (95% CI 1.9-3.9) and 4.0 (95% CI 3.0-5.1), respectively). At enrolment, patients were overall moderately adherent to maintenance therapy, with limited changes over the study. The overall incidence of adverse events was similar in the two groups (29.5% and 27.3% of patients, respectively).</p><p><strong>Conclusions: </strong>Patients using MF/IND/GLY with digital support had similar improvements in asthma control to those receiving ICS/LABA/LAMA alone, with minimal changes in adherence. These results illustrate the challenges in evaluating asthma control and adherence in non-interventional studies. Further studies are required to evaluate the value of digital support systems and how they can be used to optimise inhaler adherence.</p>","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":"11 2","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874225/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ERJ Open Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1183/23120541.00734-2024","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Poor adherence to asthma maintenance therapy is associated with worse outcomes. A solution could be digital adherence support. This study evaluated asthma control and adherence in patients using mometasone furoate/indacaterol/glycopyrronium (MF/IND/GLY) with a digital support system or using any inhaled corticosteroid/long-acting β2-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) combination without support.
Methods: This prospective, non-interventional, multicentre, open-label study enrolled adults with asthma in Germany. Prior to inclusion, treatment was initiated with MF/IND/GLY with digital support or with any ICS/LABA/LAMA without digital support. The primary end-point was change in Asthma Control Test (ACT) at 6 months.
Results: Of 222 and 203 patients in the MF/IND/GLY plus digital support and ICS/LABA/LAMA groups, 76.1% and 74.9% completed follow-up, respectively. Baseline mean ACT total scores were 17.0 and 14.7, with mean changes from baseline at 6 months of 3.0 and 4.1, respectively; following propensity matching (n=92 per group), mean changes were similar in the two groups, with overlapping 95% confidence intervals (2.9 (95% CI 1.9-3.9) and 4.0 (95% CI 3.0-5.1), respectively). At enrolment, patients were overall moderately adherent to maintenance therapy, with limited changes over the study. The overall incidence of adverse events was similar in the two groups (29.5% and 27.3% of patients, respectively).
Conclusions: Patients using MF/IND/GLY with digital support had similar improvements in asthma control to those receiving ICS/LABA/LAMA alone, with minimal changes in adherence. These results illustrate the challenges in evaluating asthma control and adherence in non-interventional studies. Further studies are required to evaluate the value of digital support systems and how they can be used to optimise inhaler adherence.
背景:哮喘维持治疗依从性差与较差的预后相关。一个解决方案可能是数字依从性支持。本研究评估了使用糠酸莫米松/吲达卡特罗/甘替罗钠(MF/IND/GLY)和数字支持系统或使用任何吸入皮质类固醇/长效β2激动剂/长效muscarinic拮抗剂(ICS/LABA/LAMA)联合使用无支持的患者的哮喘控制和依从性。方法:这项前瞻性、非干预性、多中心、开放标签的研究在德国招募了患有哮喘的成年人。在纳入之前,治疗开始时使用有数字支持的MF/IND/GLY或任何没有数字支持的ICS/LABA/LAMA。主要终点为6个月时哮喘控制试验(ACT)的变化。结果:MF/IND/GLY加数字支持组222例,ICS/LABA/LAMA组203例,分别有76.1%和74.9%的患者完成了随访。基线平均ACT总分为17.0分和14.7分,6个月时的平均变化分别为3.0分和4.1分;根据倾向匹配(n=92每组),两组的平均变化相似,95%置信区间重叠(分别为2.9 (95% CI 1.9-3.9)和4.0 (95% CI 3.0-5.1))。在入组时,患者总体上中等程度地坚持维持治疗,在研究期间变化有限。两组不良事件的总发生率相似(分别为29.5%和27.3%)。结论:与单纯接受ICS/LABA/LAMA治疗的患者相比,使用MF/IND/GLY配合数字支持治疗的患者在哮喘控制方面有相似的改善,而依从性变化很小。这些结果说明了在非介入性研究中评估哮喘控制和依从性的挑战。需要进一步的研究来评估数字支持系统的价值,以及如何使用它们来优化吸入器依从性。
期刊介绍:
ERJ Open Research is a fully open access original research journal, published online by the European Respiratory Society. The journal aims to publish high-quality work in all fields of respiratory science and medicine, covering basic science, clinical translational science and clinical medicine. The journal was created to help fulfil the ERS objective to disseminate scientific and educational material to its members and to the medical community, but also to provide researchers with an affordable open access specialty journal in which to publish their work.