NCT02161107已完成2 期
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Grass-SPIRE in Subjects With Asthma and Grass-Induced Rhinoconjunctivitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 5
- 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 Grass-SPIRE to subjects suffering from both grass 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 grass for at least the previous two grass seasons.
- •Positive skin prick test to grass.
- •Grass-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).
- •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, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
研究组 & 干预措施
Grass-SPIRE 2
Experimental
Grass-SPIRE regimen 2 given 2 weeks apart
干预措施: Grass-SPIRE (Biological)
Placebo
Placebo Comparator
Placebo given 2 weeks apart
干预措施: Placebo (Biological)
Grass-SPIRE 1
Experimental
Grass-SPIRE regimen 1 given 2 weeks apart
干预措施: Grass-SPIRE (Biological)
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 15 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 15 weeks)
- Evaluation of change in lung function as a measure of safety and tolerability(Throughout subjects participation in the study, approximately 15 weeks)
研究者
研究点 (5)
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