NCT01955512已完成2 期
Effect of Clopidogrel on Allergen Challenge in Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel
研究概览
简要总结
In asthma, breathing in an allergen, such as house dust mite induces inflammation in the airways. This process appears to involve an interaction between two different sorts of blood cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on platelets, reduces inflammation following breathing in house dust mite in people with mild asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of asthma
- •Step one of treatment by GINA (2006) guidelines
- •baseline FEV1 >80% predicted
排除标准
- •current smoker
- •ex smoker who quit <1 year prior to study and pack history >10 pack years
- •current use of aspirin or other anticoagulant medication
- •Diagnosis or documented history of bronchopulmonary aspergillosis or uncontrolled infections
- •Any clinically significant cardiopulmonary abnormalities not related to pre-existing asthma
- •Past or present tuberculosis, systemic lupus erythematosis or multiple sclerosis
- •Any clinically significant neurological, renal, endocrine, gastrointestinal, hepatic or haematological abnormalities uncontrolled with standard treatment
- •History of psychiatric, medical or surgical disorders that may interfere with study
- •Clinical history suggestive of respiratory infection in month preceding study
- •Alcohol or recreational drug abuse
- •Diagnosis of immunodeficiency requiring treatment
- •Treatment with immunomodulators (inhaled corticosteroids in two months or oral corticosteroids in six months prior to study)
- •Ongoing allergen desensitisation therapy
- •Regular use of sedatives, hypnotics, tranquillisers
- •Positive hepatitis viral antigens or antibodies
- •Blood donation within 3 months of the study
- •Live immunisation <4 wks prior to study
- •Inability to understand directions for study assessment
- •Inability to be contacted in case of emergency
- •Participation in another study at the same time or within a prior 3-month period
研究组 & 干预措施
Placebo
Placebo Comparator
Arm given placebo
干预措施: Placebo (Drug)
Clopidogrel
Experimental
Group given clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Change in sputum eosinophils following allergen challenge in the presence and absence of clopiodgorel
时间窗: 8 days
次要结局
- Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second(8 days)
- Change in sputum tissue factor inhibitor concentration following allergen challenge in the presence and absence of clopidogrel(8 days)
- Change in sputum thrombin activatable finbrinolysis inhibitor concentration following allergen challenge in the presence and absence of clopidogrel(8 days)
- Change in urine fibrin degradation products and leukotriene E4 following allergen challenge in the presence and absence of clopidogrel(8 days)
- Change in sputum tissue factor concentration following allergen challenge in the presence and absence of clopidogrel(8 days)
- Change in sputum P-selectin concentration following allergen challenge in the presence and absence of clopidogrel(8 days)
- Change in peripheral blood eosinophil and platelet counts following allergen challenge in the presence and absence of clopidogrel(8 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol SupplementsMild AsthmaAllergic RhinitisNCT00466596University of North Carolina, Chapel Hill8
终止
不适用
Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable AsthmaAsthmaNCT02773628Centre Hospitalier Universitaire Saint Pierre3
Unknown
不适用
Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal ModelAsthmaNCT01204060McMaster University20
已完成
不适用
Relationship Between Degree of Domestic Environmental Fungal Exposure and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT05456178Hospices Civils de Lyon63
已完成
不适用
Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction.House Dust Mite AllergyBronchial HyperresponsivenessNCT01134757Johann Wolfgang Goethe University Hospital425