NCT02061709已完成2 期
A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Three Dose Regimens of Ragweed-SPIRE in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)
研究概览
简要总结
The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-65 years.
- •Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
- •Minimum qualifying rhinoconjunctivitis symptom scores
- •Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L.
排除标准
- •Subjects with a history of ragweed pollen induced asthma
- •A history of anaphylaxis to ragweed allergen.
- •FEV1 < 80 % of predicted.
- •Subjects who cannot tolerate Baseline Challenge in the EEC.
- •Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- •History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
- •A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
- •A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)
结局指标
主要结局
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)
时间窗: Between Baseline and approximately 25 weeks after randomisation
次要结局
- Change from Baseline in mean Total Nasal Symptom Score (TNSS)(Aproximately 25 weeks after randomisation)
- Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints(Between Baseline and approximately 25 weeks after randomisation)
- Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)(Approximately 25 weeks after randomisation)
- Number of Participants with Adverse Events as a Measure of Safety and tolerability(Approximately 28 weeks)
研究者
研究点 (10)
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