NCT01063985已完成不适用
A Comparison of Skin Prick Tests, Clinical Symptoms and Nasal Challenge Using a New Mouse Extract
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- To determine the optimal concentration of mouse extract based on the skin prick test using the nasal challenge and clinical symptoms to confirm their true mouse allergic status in a sample of people exposed to mice.
研究概览
简要总结
The purpose of this study is to test a new mouse skin test extract on people who work with mice in a lab or through animal care. It has a higher level of the major allergen and therefore may be better at diagnosing mouse allergies in this population.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposure to mouse on a regular basis through occupation or animal care. Patients must sign informed consent before completing any study procedure.
- •Healthy subjects age >18 years and <60 years
- •Females with no child bearing potential. Females are considered not to have child bearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy or bilateral oophorectomy
- •Females with child bearing potential if they fulfill the following criteria: Use of a medically accepted contraceptive method (hormone birth control [orally, injectable, or implant for at least 2 months prior to enrollment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom), and have a negative pregnancy test
- •Patients who are able to understand the information given, be compliant with the protocol including investigational product administration and visit schedules as well as recording information requested by the investigators.
- •Exclusion Criteria
- •Present history of tobacco smoking (within the past 12 months or ex-smoker with >10 pack years).
- •Illicit drug use.
- •Asthma requiring treatment with medications other than beta-2 inhaled agonists and leukotriene inhibitors.
- •Patients with a history of asthma or wheezing with an FEV1 <80%
- •Subjects who have taken a nasal adrenergic agonist the day of the procedure
- •Use of H1 antagonists, leukotriene inhibitors, tricyclic antidepressants, phenothiazines, nasal antihistamines, or ocular antihistamines within 5 days prior to the testing.
- •Subjects who are on nasal, oral steroids, or ketotifen within 2 weeks of the procedure
- •Subjects taking beta blockers, ace inhibitors, continuous systemic corticotherapy, immunosuppressive drugs, reserpine, clonidine or monoamine oxidase inhibitors.
- •Patients who have received any desensitization for mouse allergen in the past 5 years
- •Ongoing immunotherapy with any other allergen.
- •Patients with any nasal condition that could confound the efficacy or safety assessments, for example nasal polyposis, nasal ulcers, nasal surgery 6 weeks prior to study or tumors.
- •Patients with any past or current clinically significant condition that may affect the patient's participation or the outcome of the study to the discretion of the investigator. These include, but are not limited to, anaphylaxis with cardio-respiratory symptoms (to any known or unknown source including mice exposure), chronic urticaria and angioedema unless related to mouse exposure, severe atopic dermatitis, malignancy, cardiovascular, hepatic, renal, hematological, neurological, immunological, and endocrine disease.
- •Hyper responsiveness to glycerin control on nasal challenge as defined by a non-cumulative score of 5 on the nasal challenge symptom score.
- •Although fetal risk is not expected to be high, women of childbearing potential who may be pregnant or who are not on adequate contraceptives will be excluded from the study (as defined in inclusions). In addition pregnant or breastfeeding women will also be excluded from the study.
- •Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study.
排除标准
- 未提供
结局指标
主要结局
To determine the optimal concentration of mouse extract based on the skin prick test using the nasal challenge and clinical symptoms to confirm their true mouse allergic status in a sample of people exposed to mice.
时间窗: One year
次要结局
未报告次要终点
研究者
研究点 (1)
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