...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Clinical drug investigation >Negative clinical results from a randomised, double-blind, placebo-controlled trial evaluating the efficacy of two doses of immunologically enhanced, grass subcutaneous immunotherapy despite dose-dependent immunological response
【24h】

Negative clinical results from a randomised, double-blind, placebo-controlled trial evaluating the efficacy of two doses of immunologically enhanced, grass subcutaneous immunotherapy despite dose-dependent immunological response

机译：来自随机，双盲，安慰剂对照试验的阴性临床结果，该试验评估了两种剂量的免疫增强草皮下免疫治疗的剂量，尽管剂量依赖性免疫反应

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Objective: Specific immunotherapy is the only treatment for the underlying allergic disease in patients with respiratory allergies. The primary objective of this trial was to evaluate the efficacy and safety of two maintenance doses of immunologically enhanced, standardised quality (SQ+) grass subcutaneous immunotherapy (SCIT) [4,000 SQ+ and 15,000 SQ+; AVANZ? Phleum pratense (ALK)] compared with placebo. Methods: This was a randomised, double-blind, placebo-controlled, phase II/III trial. The primary evaluation was based on the combined rhinoconjunctivitis score during the entire grass pollen season. Adult subjects with grass pollen-induced allergic rhinoconjunctivitis interfering with usual activities or sleep despite symptomatic medication use, were enrolled. Results: Four hundred and fifty subjects were randomised to receive either 4,000 SQ+ (n = 150), 15,000 SQ+ (n = 152) or placebo (n = 148). The average grass pollen exposure was 27 grains/m3/day. No statistically significant differences between the active groups and the placebo group were found for clinical endpoints (p 0.05). Highly statistically significant (p 0.001) increases in IgG4 and IgE-blocking factor were found for both active groups versus placebo. The most frequently reported adverse events were mild-to-moderate local injection-site reactions; events were generally more frequent with 15,000 SQ+ than with 4,000 SQ+ and placebo. The most common adverse events leading to premature discontinuation from the trial were anaphylactic reactions (one subject from the placebo group and five subjects from the 15,000 SQ+ group). Conclusions: The inconclusive results were most probably influenced by a very low grass pollen season. Other factors such as the extent of the pre-seasonal treatment could potentially have contributed. The tolerability profile was acceptable for further development.
机译：目的：特异性免疫疗法是呼吸道过敏患者潜在过敏性疾病的唯一治疗方法。该试验的主要目的是评估两种维持剂量的免疫学上提高的，标准化质量的（SQ +）草皮下免疫疗法（SCIT）[4,000 SQ +和15,000 SQ +; AVANZ？ Phleum pratense（ALK）]与安慰剂比较。方法：这是一项随机，双盲，安慰剂对照的II / III期试验。初步评估是基于整个草花粉季节的鼻结膜炎综合评分。入选了患有草花粉诱导的变应性鼻结膜炎，尽管使用对症药物但仍干扰正常活动或睡眠的成年受试者。结果：450位受试者被随机分配接受4,000 SQ +（n = 150），15,000 SQ +（n = 152）或安慰剂（n = 148）。草花粉的平均暴露量为27粒/立方米/天。活性组和安慰剂组之间在临床终点方面未发现统计学上的显着差异（p> 0.05）。与安慰剂相比，两个活性组的IgG4和IgE阻断因子均具有统计学上的显着提高（p <0.001）。最常见的不良反应是轻度至中度的局部注射部位反应。 15,000 SQ +的事件通常比4,000 SQ +和安慰剂的事件更为频繁。导致试验过早终止的最常见不良事件是过敏反应（安慰剂组1名受试者和15,000 SQ +组5名受试者）。结论：不确定的结果很可能受到非常低的草花粉季节的影响。其他因素（例如，季前治疗的程度）可能也有影响。公差曲线对于进一步开发是可以接受的。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号