Center for Managing Chronic Disease, University of Michigan School of Public Health, Ann Arbor, MI 48109-2029, USA.
J Allergy Clin Immunol. 2012 Aug;130(2):362-7.e9. doi: 10.1016/j.jaci.2012.03.028. Epub 2012 Apr 25.
Information surrounding the long-term safety of combination inhaled corticosteroid/long-acting β(2)-adrenergic agonist medications in African American asthmatic patients is limited.
We sought to assess safety and asthma control with a budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide over 1 year in African American patients.
This 52-week, randomized, double-blind, parallel-group, multicenter, phase 3B safety study (NCT00419952) was conducted in 742 self-reported African American patients 12 years or older with moderate-to-severe asthma previously receiving medium- to high-dose inhaled corticosteroids. After 2 weeks using a 320 μg twice-daily budesonide pMDI, patients were randomized 1:1 to 320/9 μg twice-daily budesonide/formoterol pMDI or 320 μg twice-daily budesonide pMDI.
Both treatments were well tolerated. Asthma exacerbation incidence and rate (per patient-treatment year) were lower with budesonide/formoterol versus budesonide (incidence, 7.7% vs 14.0% [P= .006]; rate ratio, 0.615 [P= .002]). Time to first asthma exacerbation was longer (P= .018) with budesonide/formoterol versus budesonide. The most common adverse events, regardless of study drug relationship, were headache (9.5% and 7.7%), nasopharyngitis (6.9% and 8.0%), sinusitis (4.0% and 6.3%), and viral upper respiratory tract infection (5.8% and 4.4%) for budesonide/formoterol and budesonide, respectively. Serious adverse events occurred in 12 and 15 patients, respectively; none were considered drug related. No substantial or unexpected patterns of abnormalities were observed in laboratory, electrocardiographic, or Holter monitoring assessments. Hospitalization caused by asthma exacerbation occurred in 0 and 4 patients in the budesonide/formoterol and budesonide groups, respectively. Pulmonary function and asthma control measures generally favored budesonide/formoterol.
In this population budesonide/formoterol pMDI was well tolerated over 12 months, with a safety profile similar to that of budesonide; the asthma exacerbation rate was reduced by 38.5% versus budesonide.
关于联合吸入皮质激素/长效β（2）-肾上腺素能激动剂药物在非裔美国哮喘患者中的长期安全性信息有限。
我们旨在评估布地奈德/福莫特罗压力定量吸入器（pMDI）与布地奈德在非裔美国患者中使用 1 年的安全性和哮喘控制情况。
这是一项为期 52 周、随机、双盲、平行组、多中心、3B 期安全性研究（NCT00419952），纳入了 742 名自我报告的年龄在 12 岁及以上的非裔美国中重度哮喘患者，他们之前接受过中至高剂量吸入皮质激素治疗。在使用 320μg 布地奈德 pMDI 每日两次治疗 2 周后，患者以 1:1 的比例随机分配至 320/9μg 布地奈德/福莫特罗 pMDI 或 320μg 布地奈德 pMDI 每日两次。
两种治疗方法均具有良好的耐受性。与布地奈德相比，布地奈德/福莫特罗的哮喘恶化发生率和发生率（每患者-治疗年）更低（发生率：7.7%比 14.0%[P=.006]；率比：0.615[P=.002]）。与布地奈德相比，布地奈德/福莫特罗的首次哮喘恶化时间更长（P=.018）。无论与研究药物的关系如何，最常见的不良事件均为头痛（9.5%和 7.7%）、鼻咽炎（6.9%和 8.0%）、鼻窦炎（4.0%和 6.3%）和病毒性上呼吸道感染（5.8%和 4.4%），分别为布地奈德/福莫特罗和布地奈德。各有 12 名和 15 名患者发生严重不良事件，均与药物无关。实验室、心电图或动态心电图监测评估未观察到实质性或意外的异常模式。因哮喘恶化而住院的患者分别为布地奈德/福莫特罗组 0 例和布地奈德组 4 例。肺功能和哮喘控制措施总体上有利于布地奈德/福莫特罗。
在该人群中，布地奈德/福莫特罗 pMDI 耐受良好，持续 12 个月，安全性与布地奈德相似；与布地奈德相比，哮喘恶化率降低了 38.5%。
