NCT05196282Unknown不适用
An Open-label, 6-arm Parallel Group, Single-center Preference Clinical Study on the Effects of Smoking Cessation or Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Adult Smokers Who Have Been Diagnosed With Inflammatory Bowel Disease (IBD) and Are Under Treatment.
适应症
试验速览
- 阶段
- 不适用
- 发起方
- HaFCED e.K.
- 入组人数
- 100
- 主要终点
- Activity Scores
研究概览
简要总结
The main goal of this study is to evaluate the effects of smoking cessation or switching from cigarette smoking to THS (tobacco heat system) on the clinical course of UC (ulcerative colitis) and CD (Crohn´s disease) in adult smokers who were diagnosed with IBD and are under treatment.
Measures using validated/standardized assessment methods and self-reported outcomes will be assessed in patients who stop smoking or switch from smoking to using THS over the investigational period of 6 months, relative to smokers who continue smoking cigarettes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Activity Scores
时间窗: 6.5 months
CDAI, Crohn's disease activity index - Range from 0-600. The higher the more active
次要结局
未报告次要终点
研究者
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