EUCTR2007-004538-18-HU进行中（未招募）不适用
A randomized doble-blind placebo-controlled study to assess the safety in a one-year of orally administered microencapsulated ragweed pollen extract
Curalogic A/S0 个研究点目标入组 200 人开始时间: 2007年10月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects eligible for enrollment into this study are female and males who:
- •1. Are between 18 and 65 years of age and are in general good health;
- •2. Have a history of two consecutive seasons of fall, seasonal allergic rhinitis that has required repeated treatment with antihistamines, leukotriene antagonists, and/or nasal steroids;
- •3. Have a positive puncture skin test to a standardized ragweed (Ambrosia artemisiifolia) pollen extract (= 150 Amb a 1 units/ml) with a:·SE (Sum of erythema) of at least 40 mm, and·Diameter of wheal of at least 5 mm;
- •4. Have a ragweed (Ambrosia artemisiifolia) specific IgE level of at least 0.70 kU/L using the Pharmacia & Upjohn ImmunoCAP assay;
- •5. Are willing to remain in the study center’s defined ragweed area for the entire pollen season;
- •6. Will be available for clinic visits for the duration of the study;
- •7. Have a negative urine pregnancy test (women of childbearing potential). In women of childbearing age, who are sexually active, they must be consistently using a highly effective method of birth control (oral contraceptive, intra-uterine device [IUD], condom plus spermicide, Depo-Provera or other acceptable contraceptive methods, [abstinence and celibacy will be accepted only with written confirmation by subject]) for at least one month prior to study entry and will continue to use this method consistently for the duration of the study;
- •8. Are able to understand the protocol and comply with study instructions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Are pregnant and/or breast feeding;
- •2. Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk;
- •3. Have perennial or structurally related rhinitis, including vasomotor rhinitis, that will interfere with the evaluation of symptoms due to ragweed allergy i.e. require treatment of their allergic symptoms with antihistamines or nasal steroids during the months of December and January;
- •4. Have a routine sleeping pattern between the hours of approximately 6:00 am to 6:00 pm;
- •5. Are currently receiving immunotherapy to any allergens and/or have received ragweed immunotherapy within 5 years of the Screening Visit (immunotherapy to other allergens than ragweed discontinued within 90 days of Screening Visit is allowed);
- •6. Are asthmatic requiring daily controller” medications (inhaled corticosteroids, cromolyn-type drugs, long-acting bronchodilators, leukotriene antagonists) or use rescue medicines” (albuterol or similar short-acting bronchodilators) more than 4 times per week at any time during the year or has a FEV1<80% of the predicted value;
研究者
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