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首页> 外文期刊>Pulmonary therapy. >Nocturnal Asthma: Proof-of-Concept Open-Label Study with Delayed-Release Prednisone
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Nocturnal Asthma: Proof-of-Concept Open-Label Study with Delayed-Release Prednisone

机译：夜间哮喘：延迟发布泼尼松的概念验证开放标签研究

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Introduction Many inflammatory conditions, such as asthma, show circadian symptoms that are worse at night. Delayed-release prednisone was developed for bedtime administration to optimize inhibition of nocturnally elevated pro-inflammatory cytokines. A proof-of-concept study was undertaken to examine the impact of delayed-release prednisone on nocturnal awakenings in patients with asthma requiring treatment with oral steroids. Methods In this single-center, open-label study, patients receiving long-term treatment with conventional prednisone administered at 08:00?h were switched to 4?weeks of treatment with the same dose of delayed-release prednisone given at 22:00?h. The primary efficacy endpoint was the change in number of nocturnal awakenings during the final 2?weeks of each treatment phase. Results Seven patients received treatment with delayed-release prednisone. Mean nocturnal awakenings because of asthma decreased from 10.0?±?5.45 with conventional prednisone to 2.1?±?4.41 with delayed-release prednisone, a mean reduction of ?7.9?±?6.07 (82.7% reduction). Delayed-release prednisone was generally well tolerated, and there were no unexpected safety findings. Conclusions Although the size of the efficacy population was too small to detect any statistically significant changes in nocturnal asthma control, this proof-of-concept study suggests that nighttime administration of delayed-release prednisone provides better asthma symptom control compared with morning administration of conventional prednisone. Funding Horizon Pharma, Inc (formerly Nitec Pharma GmbH).
机译：简介许多炎症性疾病（例如哮喘）的昼夜节律症状在夜间更为严重。开发了延迟释放的泼尼松用于就寝时间，以优化对夜间升高的促炎细胞因子的抑制。进行了一项概念验证研究，以检查延迟释放的泼尼松对需要口服类固醇治疗的哮喘患者夜间觉醒的影响。方法在这项单中心，开放标签的研究中，将在08：00？h接受常规泼尼松长期治疗的患者转换为在22:00接受相同剂量的延迟泼尼松治疗的4周。 ？H。主要疗效终点是每个治疗阶段的最后2周内夜间觉醒次数的变化。结果7例患者接受了泼尼松缓释治疗。哮喘引起的平均夜间觉醒从常规泼尼松的10.0±±5.45降至延迟释放的泼尼松的2.1±±4.41，平均减少了±7.9±6.07（减少了82.7％）。延迟释放的泼尼松通常耐受性良好，没有意外的安全性发现。结论尽管功效人群的规模太小，无法检测出夜间哮喘控制中的任何统计学上显着的变化，但这项概念验证研究表明，与传统的泼尼松早晨应用相比，夜间给予延迟释放的泼尼松可以更好地控制哮喘的症状。为Horizo​​n Pharma，Inc（前身Nitec Pharma GmbH）提供资金。

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