NCT00802438已完成不适用
Eosinophilic Airway Inflammation: Relationship to Remodeling and Modulation by Mepolizumab
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).
研究概览
简要总结
A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy cells called eosinophils which are produced by the body in response to allergen exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Males or females age 18 to 50 yrs,
- •History of asthma based upon presence of asthma symptoms such as cough, shortness of breath, wheeze or chest tightness,
- •positive skin-prick test to a House Dust Mite extract,
- •Forced expiratory volume at one second >70% predicted pre-albuterol, > 80% predicted post albuterol
- •>12% increase in Forced expiratory volume at one second following inhaled albuterol (180 µg) and/or
- •airway responsiveness to methacholine (PC20 <8mg/ml).
- •> 20% immediate drop in FEV1 following inhaled antigen challenge.
- •Safety laboratory assessments within normal ranges (labs to include complete blood count with differential, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, Prothrombin time, Partial Thromboplastin Time, and platelet count)
- •Female subjects of child-bearing potential must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2 and agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can include abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives).
- •In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.
排除标准
- •Use of inhaled or systemic corticosteroids or leukotriene inhibitors within 1 month of screening.
- •Treatment with Omalizumab (anti-IgE) within 9 months of screening visit
- •Concomitant use of any other monoclonal antibody
- •Respiratory infection within 4 weeks of study
- •Unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the previous 2 weeks.
- •Female subjects who are pregnant, nursing or have a pregnancy planned during the course of study
- •Current smokers (defined as smoked within the last year) or a former smoker with a history of >5 pack years.
- •Major health problems such as heart disease, type I and II diabetes or lung diseases other than asthma. Decisions regarding this criteria will be based upon the judgment of the investigator.
- •Previous malignancy.
- •Medication other than for asthma, allergies or contraception and that the investigator feels may interfere with the conduct of study (e.g. monoamine oxidase inhibitors and B-adrenergic antagonists in any form)
- •Known history of allergic reaction to previous antibody administration.
- •Prior treatment with an anti-interleukin-5 monoclonal antibody,
- •Use of an investigational drug within 30 days of entering the study,
- •History of noncompliance with medical regimens or subjects who are considered unreliable.
研究组 & 干预措施
Mepolizumab
Experimental
up to 3 monthly doses of 750mg i.v. mepolizumab
干预措施: mepolizumab (Biological)
结局指标
主要结局
The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).
时间窗: before and after up to 3 months of Mepo.
Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge. This was done via differential cell count using Hema-3 stain. Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations. The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).
次要结局
- Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab(before and after up to 3 months of Mepo)
研究者
研究点 (2)
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