布地奈德/福莫特罗干粉吸入剂与布地奈德干粉吸入剂治疗哮喘儿童（6-<12 岁）的疗效和安全性比较。

Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years).

机构信息

Colorado Allergy & Asthma Centers, P.C., Denver, Colorado.

AstraZeneca R&D, Gothenburg, Sweden.

出版信息

Ann Allergy Asthma Immunol. 2017 Apr;118(4):489-499.e1. doi: 10.1016/j.anai.2017.01.020. Epub 2017 Mar 1.

DOI:10.1016/j.anai.2017.01.020

PMID:28256307

Abstract

BACKGROUND

The efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) have been demonstrated in patients with asthma at least 12 years old.

OBJECTIVE

To evaluate the efficacy of 2 formoterol doses added to budesonide as fixed combinations vs budesonide alone in children 6 to younger than 12 years with asthma.

METHODS

This randomized, double-blinded, parallel-group, multicenter study (NCT02091986; CHASE 3) included children 6 to younger than 12 years with asthma previously receiving a medium-dose inhaled corticosteroid (ICS) or an ICS plus a long-acting β-agonist. Children symptomatic during a 7-28-day run-in on low-dose ICS, 1 inhalation of budesonide dry powder inhaler 90 μg twice daily (BID), were randomized to receive 2 inhalations of budesonide/formoterol pMDI 80/4.5 μg (160/9 μg) BID (n = 92), budesonide/formoterol pMDI 80/2.25 μg (160/4.5 μg) BID (n = 95), or budesonide pMDI 80 μg (160 μg) BID (n = 92) for 12 weeks.

RESULTS

Change in forced expiratory volume in 1 second from baseline to 1 hour after dosing (primary end point), change in forced expiratory volume in 1 second 15 minutes after dosing, and peak expiratory flow 1 hour after dosing at week 12 were statistically significantly greater for budesonide/formoterol 160/9 μg vs budesonide (P ≤ .015 for all comparisons), but not for budesonide/formoterol 160/4.5 μg vs budesonide. Bronchodilator effects, evident 15 minutes after the dose on day 1, were maintained at week 12. Incidence of protocol-defined asthma exacerbations and improvements in asthma symptom-related and quality-of-life outcomes were similar across treatments. There were no notable safety differences among treatments.

CONCLUSION

Budesonide/formoterol pMDI 160/9 μg showed statistically significant and clinically meaningful lung function improvements vs budesonide pMDI 160 μg, demonstrating appropriateness as a therapeutic option for children 6 to younger than 12 years with asthma symptomatic on ICS alone.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02091986.

摘要

背景

布地奈德/福莫特罗定量气雾剂（pMDI）在至少 12 岁的哮喘患者中的疗效和安全性已得到证实。

目的

评估两种福莫特罗剂量与布地奈德联合固定剂量在 6 岁以下儿童哮喘中的疗效。

方法

这项随机、双盲、平行分组、多中心研究（NCT02091986；CHASE 3）纳入了先前接受中剂量吸入性皮质类固醇（ICS）或 ICS 加长效β-激动剂治疗的 6 岁以下儿童哮喘患者。在低剂量 ICS 为期 7-28 天的导入期有症状的儿童，每日两次（BID）吸入布地奈德干粉吸入剂 90μg 1 次（BID），随机接受布地奈德/福莫特罗 pMDI 80/4.5μg（160/9μg）BID（n=92）、布地奈德/福莫特罗 pMDI 80/2.25μg（160/4.5μg）BID（n=95）或布地奈德 pMDI 80μg（160μg）BID（n=92）治疗 12 周。

结果

从基线到给药后 1 小时用力呼气量（FEV1）的变化（主要终点）、给药后 15 分钟时 FEV1 的变化以及给药后 1 小时时呼气峰流量在第 12 周时，布地奈德/福莫特罗 160/9μg 与布地奈德相比，统计学上有显著改善（所有比较均为 P≤0.015），但布地奈德/福莫特罗 160/4.5μg 与布地奈德相比无显著差异。在第 1 天，在剂量后 15 分钟即可观察到支气管扩张剂效应，并在第 12 周时仍保持。哮喘加重的发生率和哮喘症状相关及生活质量改善的情况在各治疗组之间相似。各治疗组之间未见明显安全性差异。