TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life

IF 2.8 3区医学 Q1 Medicine

International Journal of Chronic Obstructive Pulmonary Disease Pub Date : 2024-02-23 DOI:10.2147/copd.s445858

Luca Richeldi, Pietro Schino, Elena Bargagli, Alberto Ricci, Alberto Rocca, Francesca Marchesani, Alfio Pennisi, Gianna Camiciottoli, Maria D'Amato, Francesco Macagno, Ulrica Scaffidi Argentina, Eleonora Ingrassia, Alessio Piraino

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引用次数: 0

Abstract

Purpose: The TRITRIAL study assessed the effects of beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed combination in patients with chronic obstructive pulmonary disease (COPD) in a real-world setting, focusing on patient’s experience and perspective through the use of patients reported outcomes.
Patients and Methods: TRITRIAL was a multicenter, prospective, observational study conducted on patients with moderate-severe COPD treated with BDP/FF/G fixed therapy for 12 months. The main objective was to evaluate the impact of BDP/FF/G on health status through the COPD Assessment Test (CAT) score. Additional assessments included adherence and satisfaction, measured by the TAI-10/12 questionnaire and a specifically designed eight-item questionnaire, quality of life through the EQ-5D-5L test, sleep quality through the COPD and Asthma Sleep Impact Scale (CASIS), as well as safety and disease-related outcomes.
Results: Data from 655 patients were analyzed in the study. The mean total CAT score significantly improved (from 22.8 at baseline to 18.1 at 6 months and 16.5 at 12 months; p < 0.0001), as well as all the eight CAT sub-items, which decreased on average by 0.5– 0.9 points during the study. Adherence and usability of the inhaler also improved during the study, with a decrease in poor compliance (from 30.1% to 18.3%) and an increase in good compliance (from 51.8% to 58.3%) according to the TAI score. Patients also benefited from significantly improved quality of life (EQ Index from 0.70 to 0.80; EQ-5D VAS score from 55.1 to 63.1) and sleep quality (CASIS score from 41.1 to 31.8). Finally, patients reported a significant reduction in exacerbation during the past 12 months.
Conclusion: TRITRIAL showed that the BDP/FF/G fixed combination is effective and safe in patients with moderate-severe COPD and poorly controlled disease, improving patients’ HRQoL, sleep quality, adherence and inhaler usability and reducing COPD symptoms and the risk of exacerbation in a real-life setting.

Keywords: beclometasone/formoterol/glycopyrronium, chronic obstructive pulmonary disease, real-world, fixed triple therapy, adherence, patient-reported outcomes

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TRITRIAL：在意大利真实生活背景下，贝氯美松/福莫特罗/甘草酸铵固定三联疗法对慢性阻塞性肺病患者健康状况和坚持治疗的影响

目的：TRITRIAL 研究评估了倍氯米松丙酸盐/福莫特罗富马酸盐/甘草酸铵（BDP/FF/G）固定组合疗法在实际环境中对慢性阻塞性肺疾病（COPD）患者的疗效，通过使用患者报告的结果重点关注患者的体验和观点：TRITRIAL 是一项多中心、前瞻性、观察性研究，对象是接受 BDP/FF/G 固定疗法治疗 12 个月的中重度慢性阻塞性肺疾病患者。主要目的是通过慢性阻塞性肺病评估测试（CAT）评分评估 BDP/FF/G 对健康状况的影响。其他评估包括通过 TAI-10/12 问卷和专门设计的八项调查问卷测量的依从性和满意度、通过 EQ-5D-5L 测试测量的生活质量、通过 COPD 和哮喘睡眠影响量表（CASIS）测量的睡眠质量，以及安全性和疾病相关结果：研究分析了 655 名患者的数据。CAT的平均总分有了明显提高（从基线时的22.8分降至6个月时的18.1分和12个月时的16.5分；P< 0.0001），CAT的所有8个分项也有了明显提高，在研究期间平均降低了0.5-0.9分。在研究期间，吸入器的依从性和可用性也得到了改善，根据 TAI 评分，依从性差的患者减少了（从 30.1% 降至 18.3%），依从性好的患者增加了（从 51.8% 升至 58.3%）。患者的生活质量（EQ 指数从 0.70 升至 0.80；EQ-5D VAS 分数从 55.1 升至 63.1）和睡眠质量（CASIS 分数从 41.1 升至 31.8）也得到了明显改善。最后，患者表示在过去的12个月中病情加重的情况明显减少：TRITRIAL表明，BDP/FF/G固定联合疗法对中重度慢性阻塞性肺疾病和病情控制不佳的患者有效且安全，可改善患者的HRQoL、睡眠质量、依从性和吸入器可用性，并在真实环境中减少慢性阻塞性肺疾病症状和病情加重的风险。关键词：倍氯米松/福莫特罗/甘丙侖；慢性阻塞性肺疾病；真实世界；固定三联疗法；依从性；患者报告结果

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来源期刊

International Journal of Chronic Obstructive Pulmonary Disease RESPIRATORY SYSTEM-

CiteScore

5.10

自引率

10.70%

发文量

372

审稿时长

16 weeks

期刊介绍： An international, peer-reviewed journal of therapeutics and pharmacology focusing on concise rapid reporting of clinical studies and reviews in COPD. Special focus will be given to the pathophysiological processes underlying the disease, intervention programs, patient focused education, and self management protocols. This journal is directed at specialists and healthcare professionals

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