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首页> 外文期刊>The journal of asthma >Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma
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Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

机译：沙丁胺醇多剂量干粉吸入器在持续性哮喘患者中的12周和52周安全性

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Objective: Evaluate the safety of albuterol multidose dry powder inhaler (MDPI), a novel, inhalation-driven device that does not require coordination of actuation with inhalation, in patients with persistent asthma. Methods: We report pooled safety data from two 12-week, multicenter, randomized, double-blind, repeat-dose, parallel-group studies and the 12-week double-blind phase of a 52-week multicenter safety study as well as safety data from the 40-week open-label phase of the 52-week safety study. In each study, eligible patients aged >= 12 years with persistent asthma received placebo MDPI or albuterol MDPI 180 mu g (2 inhalations x 90 mu g/inhalation) 4 times/day for 12 weeks. In the 40-week open-label phase of the 52-week safety study, patients received albuterol MDPI 180 mu g (2 inhalations x 90 mu g/inhalation) as needed (PRN). Results: During both 12-week studies and the 12-week double-blind phase of the 52-week study, adverse events were more common with placebo MDPI (50%; n = 333) than albuterol MDPI (40%; n = 321); most frequent were upper respiratory tract infection (placebo MDPI 11%, albuterol MDPI 10%), nasopharyngitis (6%, 5%), and headache (6%, 4%). Incidences of beta(2)-agonist-related events (excluding headache) during the pooled 12-week dosing periods were low (<= 1%) in both groups. The safety profile with albuterol MDPI PRN during the 40-week open-label phase [most frequent adverse events: nasopharyngitis (12%), sinusitis (11%), upper respiratory tract infection (9%)] was similar to that observed during the 12-week pooled analysis. Conclusions: The safety profile of albuterol MDPI 180 mu g in these studies was comparable with placebo MDPI and consistent with the well-characterized profile of albuterol in patients with asthma.
机译：目的：评估沙丁胺醇多剂量干粉吸入器（MDPI）在持续性哮喘患者中的安全性，该新型吸入驱动装置不需要致动与吸入协调。方法：我们报告了来自两个12周，多中心，随机，双盲，重复剂量，平行组研究以及52周多中心安全研究的12周双盲阶段的汇总安全性数据以及安全性来自52周安全研究的40周开放标签阶段的数据。在每项研究中，年龄≥12岁且患有持续性哮喘的合格患者接受安慰剂MDPI或沙丁胺醇MDPI 180μg（2吸入x 90μg /吸入），每天4次，持续12周。在一项为期52周的安全性研究的40周开放标签阶段中，患者应根据需要（PRN）接受180μg沙丁胺醇MDPI（2次吸入x 90μg /吸入）。结果：在为期52周的12周研究和为期12周的双盲研究中，安慰剂MDPI（50％; n = 333）比沙丁胺醇MDPI（40％; n = 321）更常见。 ）;最常见的是上呼吸道感染（安慰剂MDPI为11％，沙丁胺醇MDPI为10％），鼻咽炎（6％，5％）和头痛（6％，4％）。两组患者在合并的12周用药期间内与beta（2）-激动剂相关的事件（不包括头痛）的发生率均较低（<= 1％）。沙丁胺醇MDPI PRN在40周开放标签阶段的安全性[最常见的不良事件：鼻咽炎（12％），鼻窦炎（11％），上呼吸道感染（9％）]与在治疗期间观察到的相似。 12周汇总分析。结论：在这些研究中，沙丁胺醇180 mg的安全性与安慰剂MDPI相当，并且与哮喘患者沙丁胺醇的良好特征相吻合。

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