JPRN-jRCT2080223342已完成3 期
CS-8958 Phase 3 study - A randomized, single-blind, placebo-controlled study of nebulized CS-8958 in the treatment of influenza virus infection
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 534
研究概览
简要总结
CS-8958 nebulizer inhaler 160 mg was effective in adults and children aged 10 years and older with influenza A or B virus infection. The incidence and content of adverse events did not differ between CS-8958 and placebo-treated subjects, and there were no safety concerns associated with a single inhaled dose of CS-8958 nebulizer 160mg.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 10age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Tested positive for influenza A or B by the rapid diagnostic test
- •Body temperature (axillary) at informed consent >= 37.5 degrees
- •Within 36 hours of the onset of influenza symptoms at informed consent
排除标准
- •Suspected of having infection by bacteria species and/or other virus (pneumonia, bronchitis, otitis, sinusitis, etc.; including secondary infection) within 1 week before informed consent
- •History of influenza pneumonia
- •Assessed to be ineligible by the investigators, including those with serious complications
研究者
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