INTRODUCTION Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β2-agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®. METHODS This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. The study population was enriched for patients who were responsive to ICS therapy. The primary objective of the present study was to show non-inferiority of these doses, i.e. the low (80 μg) and high (320 μg) doses of MF delivered via Breezhaler® once daily, compared with the corresponding low (200 μg) and high (800 μg) doses of MF delivered via Twisthaler® once daily. The primary endpoint was 24h post-dose trough forced expiratory volume in one second (FEV1), after four weeks of treatment in patients with asthma. A secondary objective was to evaluate the efficacy of MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler® in terms of Asthma Control Questionnaire-5 (ACQ-5) after one, two, three and four weeks of treatment. RESULTS The LS mean difference in trough FEV1 after four weeks of treatment between MF low dose 80 μg (Breezhaler®) and MF low dose 200 μg (Twisthaler®) was 27 mL (95% CI -34, 89); for MF high dose 320 μg (Breezhaler®) and MF high dose 800 μg (Twisthaler®) the difference was 0 mL (95% CI -60, 61). These differences were neither clinically nor statistically significant. All treatment arms provided similar clinically relevant improvements in ACQ-5 after four weeks of treatment compared with baseline. Both treatments showed a similar safety profile with a low incidence of adverse events. CONCLUSION The similarities in effects on lung function and ACQ after four weeks of treatment demonstrate the comparability of MF at low (80 μg) and high (320 μg) doses delivered with Breezhaler® with MF at low (200 μg) and high (800 μg) doses delivered with Twisthaler®, respectively. The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.

中文翻译：

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一项随机，双盲研究，比较了通过Breezhaler®或Twisthaler®递送的两剂糠酸莫米他松在哮喘患者中的疗效和安全性。

简介糠酸莫米松（MF）是长效β2-激动剂（LABA）/ ICS indacaterol / MF固定剂量组合中的吸入皮质类固醇（ICS）成分，通过Breezhaler®递送，用于哮喘的治疗。通过Breezhaler®递送的低剂量（80μg）和高剂量（320μg）的MF有望分别与通过Twisthaler®递送的低剂量（200μg）和高剂量（800μg）的MF相媲美。方法这是一项对739名青少年和持续性哮喘成年人进行的随机，双盲，双模拟，四周平行组研究。符合条件的患者在筛选前至少要接受稳定方案的每日最大剂量的ICS治疗，至少持续四周。研究人群中增加了对ICS治疗有反应的患者。本研究的主要目的是显示这些剂量的非劣效性，也就是说，每天通过Breezhaler®递送的MF的低剂量（80μg）和高剂量（320μg），而每天通过Twisthaler®递送的相应的低剂量（200μg）和高剂量（800μg）MF。主要终点为哮喘患者经四周治疗后，在给药后的24小时内强迫呼气量（FEV1）。第二个目标是评估在经过一，二，三次哮喘控制问卷-5（ACQ-5）后，通过Breezhaler®递送的MF 80μg和320μg，以及通过Twisthaler®递送的MF 200μg和800μgMF的功效。和四个星期的治疗。结果MF低剂量80μg（Breezhaler®）和MF低剂量200μg（Twisthaler®）治疗4周后，最低谷FEV1的平均差为27 mL（95％CI -34，89）。对于MF高剂量320μg（Breezhaler®）和MF高剂量800μg（Twisthaler®），差异为0 mL（95％CI -60，61）。这些差异在临床和统计学上均无统计学意义。与基线相比，所有治疗组在治疗4周后ACQ-5的临床相关改善均相似。两种治疗均显示出相似的安全性，不良事件发生率低。结论治疗四周后对肺功能和ACQ的影响相似，表明Breezhaler®所提供的低剂量（80μg）和高剂量（320μg）的MF与低（200μg）和高（800μg）MF的可比性）分别使用Twisthaler®递送的剂量。该研究正式证明，通过Breezhaler®递送的MF不逊于通过Twisthaler®递送的ICS相应剂量的MF。