NCT00784732已完成2 期
A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
研究概览
简要总结
This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.
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
- Double (Participant, Investigator)
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
- •Positive skin prick test to ragweed allergen
- •FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -
- •Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m
- •Non-smokers and ex-smokers (≤10 pack years and >6 months of smoking abstinence).
- •Understand and sign the written informed consent
排除标准
- •Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
- •Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •Significant illness within two (2) weeks prior to initial dosing.
- •History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
3
Active Comparator
干预措施: Mometasone Furoate (Drug)
1
Experimental
干预措施: QAV680 (Drug)
2
Experimental
干预措施: QAV680 (Drug)
结局指标
主要结局
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
时间窗: TNSS: 6-8h during EEC exposure on Day 10
次要结局
- Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis(Through out study)
- Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC(During exposure in EEC)
- Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)(After 8h exposure in EEC)
- Total Ocular Symptom Score measured during exposure in the EEC(During exposure in EEC)
- Absolute eosinophil count from nasal lavage collected(During exposure in EEC)
研究者
研究点 (1)
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