EUCTR2013-001308-13-ES进行中（未招募）不适用
Biological standardization of Alternaria alternata allergen extract todetermine the biological activity in histamine equivalent units (HEP).
ABORATORIOS LETI S.L.0 个研究点开始时间: 2013年7月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Positive clinical history of inhalatory allergy to Alternaria alternata with (meaning: rhinitis and / or rhinoconjunctivitis and / or asthma)
- •-Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
- •-Subject can be male or female of any race and ethnic group.
- •-Age > and =18 years and < and = 60 years at the study inclusion day.
- •-Positive skin prick test with a standardized commercially available preparation of Alternaria alternata allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or wheal area ? 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
- •-A positive test for specific IgE to alternaria alternata (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
- •-The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ? 3 mm.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Immunotherapy in the past 5 years with an allergen preparation known
- •to interfere with the allergen to be tested (for example: fungal extracts)
- •-Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
- •-Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).
- •- Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 1 or 2
- •-Dermographism affecting the skin area at the test site at either study visit.
- •-Atopic dermatitis affecting the skin area at the test site at either study
- •-Urticaria affecting the skin area at the test site at either study visit.
- •-Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
- •-Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
- •-Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
- •-Patients with diseases or conditions that limit the use of adrenaline
- •(heart disease, severe hypertension, ..)
- •-Severe psychiatric, psychological or neurological disorders
- •-Abuse of alcohol, drugs or medicines in the previous year.
- •-Subjects who have received anti-IgE (Omalizumab).
研究者
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