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临床试验/ACTRN12607000271404
ACTRN12607000271404已完成1 期

A single centre, double blind, placebo controlled, prospective study to assess the immunogenicity and safety of orally administered killed whole cell non-typeable Haemophilus influenzae (NTHi) HI-1-164 in smokers at risk of recurrent bronchitis (Study HI-H003)

The University of Newcastle Research Associates (TUNRA) Ltd0 个研究点目标入组 64 人开始时间: 2007年5月18日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
64

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
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Smokers who had smoked at least 10 cigarettes per day for the past 2 years (1 pack year), with no medical or social reason for being unable to comply with requirements of the study, and willingness and ability to give signed informed consent.

排除标准

  • Known current chronic infection (except episodes of acute bronchitis with or without chronic bronchitis); participation in a clinical trial in the past 3 months; pregnant, breast-feeding, or women with child-bearing potential without an effective method of contraception, any patient likely to withdraw or not comply with the study protocol; any other medical reason that the medical advisor feels that a patient should not be included.

研究者

发起方
The University of Newcastle Research Associates (TUNRA) Ltd

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