NCT01398137已完成不适用
An Observational Multi-Centre Field Study to Assess Symptom Scores and Rescue Medication Usage in Subjects With a History of Ragweed Allergen-Induced Rhinoconjunctivitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Mean daily Combined Score during the site-specific ragweed pollen period
研究概览
简要总结
This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue medication usage (as measured by Rescue Medication Score as a Combined Score to inform the design of a phase III field study with ToleroMune Ragweed.
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
- 18 Years 至 65 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
Mean daily Combined Score during the site-specific ragweed pollen period
时间窗: Daily during ragweed season expected to last approximately 8 weeks
Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score
次要结局
- Mean Combined Score during the site-specific peak ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean TRSS during the site-specific ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean TRSS during the site-specific peak ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean Rescue Medication Score during the site-specific ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean Rescue Medication Score during the site-specific peak ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean component scores of the TRSS (nasal and non nasal) during the site specific ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean component scores of the TRSS (nasal and non nasal) during the site specific peak ragweed pollen period(Through 2011 ragweed season expected to last approximately 8 weeks)
- Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score during the site specific peak ragweed pollen period in a subset of the study population(Through 2011 ragweed season approximately 8 weeks)
- Weeks of partly controlled or uncontrolled asthma(Through 2011 ragweed season expected to last approximately 8 weeks)
研究者
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