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首页> 外文期刊>The journal of asthma >Budesonide/formoterol pressurized metered-dose inhaler versus budesonide: A randomized controlled trial in black patients with asthma
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Budesonide/formoterol pressurized metered-dose inhaler versus budesonide: A randomized controlled trial in black patients with asthma

机译：布地奈德/福莫特罗加压定量吸入器与布地奈德比较：黑人哮喘患者的随机对照试验

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Objective. Concerns exist that responses to long-acting β2-adrenergic agonists in black patients may differ from the general population. The efficacy and safety of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) versus budesonide dry powder inhaler (BUD DPI) were evaluated in adolescent and adult black asthma patients. Methods. This 12-week, randomized, double-blind, multicenter, phase IV US study was conducted in 311 self-reported black patients aged ≥12 years with moderate to severe persistent asthma, previously receiving medium- to high-dose inhaled corticosteroid. After 2 weeks on BUD 90 μg × 2 inhalations twice daily (bid), symptomatic patients were randomized to BUD/FM 160/4.5 μg × 2 inhalations bid or BUD 180 μg × 2 inhalations bid. Results. Improvement in predose forced expiratory volume in 1 second from baseline to the treatment mean (primary variable) was greater with BUD/FM versus BUD (0.16 vs. 0.07 L; p = .008); this effect was also observed at weeks 2, 6, and end of treatment (p ≤ .032). Greater improvements (p < .001) in peak expiratory flow with BUD/FM versus BUD were seen at first measurement and maintained during 12 weeks (morning: 25.34 vs. 7.53 L/minute, respectively; evening: 21.61 vs. 7.67 L/minute, respectively); greater improvements in daily asthma symptom score and rescue medication use were also observed (p ≤ .039). Both treatments were well tolerated, with similar safety profiles. Conclusions. In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.
机译：目的。人们担心黑人患者对长效β2-肾上腺素能激动剂的反应可能不同于一般人群。评价了布地奈德/福莫特罗（BUD / FM）加压计量吸入器（pMDI）与布地奈德干粉吸入器（BUD DPI）在青少年和成人黑色哮喘患者中的疗效和安全性。方法。这项为期12周，随机，双盲，多中心，IV期的美国研究是在311名年龄≥12岁，中度至重度持续性哮喘的自我报告黑人患者中进行的，该患者先前接受了中至高剂量吸入糖皮质激素治疗。每天两次两次接受BUD 90μg×2吸入（出价）2周后，将有症状的患者随​​机分为BUD / FM 160 / 4.5μg×2吸入两次或BUD 180μg×2吸入两次。结果。 BUD / FM与BUD相比，从基线到治疗平均值（主要变量）的用药前强制呼气量的改善在1秒钟内更大（0.16 vs. 0.07 L; p = .008）;在治疗的第2、6周和治疗结束时也观察到了这种效果（p≤.032）。首次测量时，BUD / FM相对于BUD的最大呼气流量改善更大（p <.001），并在12周内保持不变（早晨分别为25.34 vs. 7.53 L / min;晚上：21.61 vs. 7.67 L / min ， 分别）;还观察到每日哮喘症状评分和急救药物使用有更大的改善（p≤.039）。两种治疗均耐受良好，安全性相似。结论。与BUD DPI相比，在这批黑人哮喘患者中，BUD / FM pMDI可使肺功能和哮喘控制得到更大的改善，安全性相似。

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