ACTRN12606000074594已完成2 期
A multi-centre, double blind, placebo controlled, prospective study to assess safety and efficacy of orally administered killed whole cell nontypeable Haemophilus influenzae (NTHi) HI-1-164 in preventing episodes of acute bronchitis in patients with moderate to severe airway disease
Hunter Immunology Ltd0 个研究点目标入组 124 人开始时间: 2006年2月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Moderate to severe airway disease (FEV1 less than or equal to 50% of predicted value); at least two episodes of acute bronchitis in each of the past two years; no medical or social reason for being unable to comply with study requirements; willingness and availability to give informed consent.
排除标准
- •Known current infection (except bronchitis); taking of antibiotics within 4 weeks prior to visit 1; participation in a clinical trial of any vaccine or immune stimulating product (except probiotics) in the past 12 months (unless known to have received placebo treatment only); participation in a clinical trial apart from that described above, in the past 3 months); pregnant, breast-feeding, or women with child-bearing potential without an effective form of contraception; any significant medical disorder which would preclude evaluation of the patient's condition (except COPD); any subject likely to withdraw or not comply with the study protocol; any other medical reason for which the investigator feels a patient should not be included.
研究者
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