Pediatric Pulmonary Medicine, Childhood Asthma Care and Education Center, 571 S Floyd St, Suite 414, Louisville, KY 40202, USA.
Pediatrics. 2010 Sep;126(3):e565-75. doi: 10.1542/peds.2009-2970. Epub 2010 Aug 16.
To assess efficacy/tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide pMDI (primary) and twice-daily budesonide/formoterol (secondary) in children/adolescents with asthma stabilized with twice-daily budesonide/formoterol.
This 12-week multicenter, double-blind randomized controlled study (www.clinicaltrials.gov identifier NCT00646321) included 521 patients aged 6 to 15 years with mild/moderate persistent asthma. Patients stabilized during a 4- to 5-week run-in with twice-daily budesonide/formoterol pMDI 40/4.5 microgx2 inhalations (160/18 microg daily) received twice-daily budesonide/formoterol pMDI 40/4.5 microgx2 inhalations (160/18 microg daily), once-daily budesonide/formoterol pMDI 80/4.5 microgx2 inhalations (160/9 microg daily; evening), or once-daily budesonide pMDI 80 microgx2 inhalations (160 microg daily; evening).
Once- or twice-daily budesonide/formoterol was more effective than budesonide for evening peak expiratory flow (primary variable) at the end of the 24-hour once-daily dosing interval (P<or=.027). Twice-daily budesonide/formoterol demonstrated better efficacy versus once-daily treatments for evening predose forced expiratory volume in 1 second (P<or=.011), versus budesonide for daytime/nighttime rescue medication (P<or=.023), and versus once-daily budesonide/formoterol for daytime rescue medication (last 12 hours of once-daily dosing) (P=.032). There were no significant between-group differences for daytime/nighttime asthma symptoms, nighttime awakenings attributed to asthma, or health-related quality of life. Fewer patients experienced asthma worsening (predefined criteria) with twice-daily budesonide/formoterol (8.2%) versus once-daily budesonide (15.5%) (P=.036) or once-daily budesonide/formoterol (19.6%) (P=.002). All treatments were well tolerated.
Once-daily budesonide/formoterol demonstrated significantly better efficacy than once-daily budesonide for most pulmonary-function variables. Twice-daily budesonide/formoterol (160/18 microg daily) maintenance therapy was generally more effective than stepping down to once-daily dosing (160/9 microg daily). Treatments were well tolerated, and there was no evident safety benefit for once- versus twice-daily dosing.
评估每日 1 次布地奈德/福莫特罗干粉吸入剂（pMDI）与布地奈德 pMDI（主要）和每日 2 次布地奈德/福莫特罗（次要）在接受每日 2 次布地奈德/福莫特罗治疗稳定的儿童/青少年哮喘患者中的疗效/耐受性。
这是一项为期 12 周的多中心、双盲随机对照研究（www.clinicaltrials.gov 标识符 NCT00646321），纳入了 521 名年龄为 6 至 15 岁的轻度/中度持续性哮喘患者。患者在接受每日 2 次布地奈德/福莫特罗 pMDI 40/4.5 mcgx2 吸入剂（160/18 mcg 每日）治疗 4-5 周后，接受每日 2 次布地奈德/福莫特罗 pMDI 40/4.5 mcgx2 吸入剂（160/18 mcg 每日）、每日 1 次布地奈德/福莫特罗 pMDI 80/4.5 mcgx2 吸入剂（160/9 mcg 每日；晚上）或每日 1 次布地奈德 pMDI 80 mcgx2 吸入剂（160 mcg 每日；晚上）。
与布地奈德相比，每日 1 次或 2 次布地奈德/福莫特罗在 24 小时每日 1 次给药间隔结束时（P<0.027）更能有效改善夜间峰流速。与每日 1 次布地奈德相比，每日 2 次布地奈德/福莫特罗在夜间预给药 1 秒用力呼气容积（P<0.011）、日间/夜间解救药物（P<0.023）和日间解救药物（每日 1 次治疗的最后 12 小时）（P=.032）方面表现出更好的疗效。日间/夜间哮喘症状、夜间因哮喘发作而觉醒以及健康相关生活质量方面，各组之间无显著差异。与每日 1 次布地奈德（15.5%）（P=.036）或每日 1 次布地奈德/福莫特罗（19.6%）（P=.002）相比，每日 2 次布地奈德/福莫特罗（8.2%）发生哮喘恶化（预定义标准）的患者更少。所有治疗均耐受良好。
与每日 1 次布地奈德相比，每日 1 次布地奈德/福莫特罗在大多数肺功能指标上具有显著更好的疗效。每日 2 次布地奈德/福莫特罗（160/18 mcg 每日）维持治疗通常比每日 1 次剂量减少（160/9 mcg 每日）更有效。治疗均耐受良好，每日 1 次或 2 次给药无明显安全性获益。
