NCT02061670已完成2 期
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 10
- 主要终点
- Number of subjects with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and 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 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.
- •Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
- •A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
- •Positive skin prick test to ragweed
- •Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.
排除标准
- •History of life-threatening asthma.
- •Uncontrolled asthma according to GINA
- •FEV1 of < 70 % of predicted, regardless of the cause.
- •Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- •History of severe drug allergy or anaphylactic reaction to food.
- •A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
结局指标
主要结局
Number of subjects with adverse events as a measure of safety and tolerability
时间窗: Throughout subjects participation in the study, approximately 22 weeks
次要结局
- Number of subjects with asthma exacerbations as a measure of safety and tolerability(Throughout subjects participation in the study, approximately 22 weeks)
- Evaluation of change in lung function as a measure of safety and tolerability(Throughout subjects participation in the study, approximately 22 weeks)
研究者
研究点 (10)
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