NCT03078088已完成1 期
Airway Alkalinization and Nasal Colonization
Lakshmi Durairaj1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Nasal bacterial colonization
研究概览
简要总结
The study will be a randomized, cross-over study of THAM followed by saline or saline followed by THAM in human non-CF and CF subjects to assess nasal colonization
详细描述
16 subjects per group will be randomized to receive study drug or saline followed by a wash out period and cross-over to the other treatment, three times daily for 4 days. Nasal swab will be done at baseline and after both study treatment and saline treatment for assessment of airway colonization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •16 subjects, aged 16-80, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained fom subject.
排除标准
- •Pregnant or lactating
- •Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to screening, smoked in the last 6 months.
- •CF subjects:
- •Inclusion Criteria:
- •FEV1% >35%, O2 saturation >90% on room air, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained from subject.
- •Exclusion Criteria:
- •Same as for healthy subjects.
研究组 & 干预措施
saline
Placebo Comparator
normal saline
干预措施: Saline (Drug)
treatment
Experimental
tham
干预措施: Tham (Drug)
结局指标
主要结局
Nasal bacterial colonization
时间窗: Day 5 of placebo or Tham intervention
Culture
次要结局
- Safety assessment questionnaire(Day 5 of placebo or Tham intervention)
研究者
Lakshmi Durairaj
Staff Physician
University of Iowa
研究点 (1)
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