NCT01438827已完成2 期
Avanz Phleum Pratense Maintenance Dose
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Recording of symptomatic allergy medication use
研究概览
简要总结
The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of grass pollen allergy
- •Positive skin prick test to grass
- •Positive Immunoglobulin E test to grass
排除标准
- •Other allergies overlapping the grass pollen season
- •Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)
研究组 & 干预措施
Avanz Phleum pratense 15,000 SQ+
Active Comparator
干预措施: Avanz Phleum pratense (Drug)
Avanz Phleum pratense 4,000 SQ+
Active Comparator
干预措施: Avanz Phleum pratense (Drug)
Injection with no active grass component
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Recording of symptomatic allergy medication use
时间窗: Daily recordings during the grass pollen seasons 2012
Recording of rhinoconjunctivitis symptoms
时间窗: Daily recordings during the grass pollen season 2012
次要结局
未报告次要终点
研究者
研究点 (1)
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