EUCTR2013-001310-15-ES进行中（未招募）不适用
Biological standardization of Artemisia vulgaris allergen extract to determine the biological activity in histamine equivalent units (HEP).
ABORATORIOS LETI, S.L.0 个研究点开始时间: 2013年9月5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 Artemisia vulgaris with (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 ethinic group
- •- Age ? 18 years and ? 60 years at the study inclusion day
- •- A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ? 3mm or wheal area ? 7 mm2). The 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 Artemisia vulgaris (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.
- •- Allergy symptoms during the Artemisia vulgaris pollen season.
- •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 extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach.
- •-Use of drugs that may interfere before and after with the skin reactions (for example: 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 2, before skin prick test
- •-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 visit.
- •-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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