NCT00398151已完成3 期
An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
研究概览
简要总结
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
- •Male or female outpatient 20 years of age and older
- •Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test
排除标准
- •Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
- •Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
- •Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
- •Treated with montelukast within 3 months before enrollment
- •Unable to perform acceptable, reproducible spirometry and peak flow measurement
- •Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
结局指标
主要结局
Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
次要结局
- Asthma symptoms score throughout the study
研究者
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