Department of Respiratory Medicine and Allergology, Kindai University Nara Hospital, 1248-1 Otoda-cho, Ikoma, Nara, 630-0293, Japan.
Department of Respiratory Medicine and Allergology, Kindai University Hospital, 377-2 Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan.
BMC Pulm Med. 2021 Jan 13;21(1):26. doi: 10.1186/s12890-021-01403-y.
In chronic obstructive pulmonary disease (COPD) patients, combination treatment with long-acting muscarinic antagonist (LAMA) and long-acting β2 agonist (LABA) increases forced expiratory volume in one second and reduces symptoms compared to monotherapy. In Japan, three different once-daily fixed-dose combinations (FDCs) have been prescribed since 2015, although a direct comparison of these FDCs has never been performed. The objective of the present study was to compare the effectiveness, preference, and safety of three LAMA/LABA FDCs-glycopyrronium/indacaterol (Gly/Ind), umeclidinium/vilanterol (Ume/Vil), and tiotropium/olodaterol (Tio/Olo)-in patients with COPD.
We enrolled 75 COPD outpatients (male:female ratio, 69:6; 77.4 ± 6.9 years). A prospective, randomized, crossover study was conducted on three groups using three FDCs: Gly/Ind; Ume/Vil; and Tio/Olo. Each medication was administered for 4 weeks before crossover (total 12 weeks). After each FDC administration, a respiratory function test and questionnaire survey were conducted. A comparative questionnaire survey of all three LAMA/LABA FDCs was conducted after 12 weeks (following administration of final FDC).
No significant differences in COPD Assessment Test or modified Medical Research Council dyspnea questionnaire were reported in the surveys completed after each FDC administration; no significant differences in spirometric items were observed. In the final comparative questionnaire survey, patients reported better actual feeling of being able to inhale following Gly/Ind administration compared with Tio/Olo, although no significant differences in adverse events or other evaluations were reported.
The three LAMA/LABA FDCs administered to COPD patients show similar effects and safety, although some minor individual preference was reported. Trial registration This study retrospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (number UMIN000041342, registered on August 6, 2020).
在慢性阻塞性肺疾病（COPD）患者中，与单药治疗相比，长效毒蕈碱拮抗剂（LAMA）和长效β2 激动剂（LABA）联合治疗可增加一秒用力呼气量并减轻症状。自 2015 年以来，日本已经开处了三种不同的每日一次固定剂量复方制剂（FDC），尽管从未对这些 FDC 进行过直接比较。本研究的目的是比较三种 LAMA/LABA FDC-格隆溴铵/茚达特罗（Gly/Ind）、乌美溴铵/维兰特罗（Ume/Vil）和噻托溴铵/奥达特罗（Tio/Olo）在 COPD 患者中的疗效、偏好和安全性。
我们招募了 75 名 COPD 门诊患者（男：女，69:6；77.4±6.9 岁）。对三组患者进行了前瞻性、随机、交叉研究，使用三种 FDC：Gly/Ind；Ume/Vil；和 Tio/Olo。每组药物在交叉前（共 12 周）给药 4 周。每次 FDC 给药后进行呼吸功能测试和问卷调查。在 12 周后（末次 FDC 给药后）进行所有三种 LAMA/LABA FDC 的对比问卷调查。
在每次 FDC 给药后的调查中，COPD 评估测试或改良医学研究委员会呼吸困难问卷均未见明显差异；在肺功能项目中未见明显差异。在最终的对比问卷调查中，与 Tio/Olo 相比，患者报告在服用 Gly/Ind 后能够更好地实际感受到吸气，尽管在不良事件或其他评估方面没有明显差异。
给予 COPD 患者的三种 LAMA/LABA FDC 显示出相似的疗效和安全性，尽管报告了一些轻微的个体偏好。
本研究于 2020 年 8 月 6 日在大学医院医学信息网临床试验注册中心（注册号 UMIN000041342）进行了回顾性注册。
