NCT00232999已完成2 期
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
研究概览
简要总结
This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild stable allergic asthma
- •Positive skin-prick test to at least one common aeroallergen
- •Positive methacholine challenge
- •Positive allergen-induced early- and late-phase airway bronchoconstriction
- •General good health
排除标准
- •Lung diseases other than mild allergic asthma
- •History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
- •Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
- •Use of tobacco products within one year starting study or smoking history >10 pack years
- •If female, pregnant or lactating or have positive pregnancy test at screening
结局指标
主要结局
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
次要结局
- Anti-inflammatory activity in airways
- Methacholine PC20 pre- and post-allergen challenge
研究者
研究点 (6)
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