EUCTR2012-001939-31-ES进行中（未招募）不适用
Biological standardization of Dermatophagoides pteronyssinus 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: 2012年11月29日最近更新:
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 allergy with respiratory symptoms
- •(rhinitis and / or rhinoconjunctivitis and / or asthma) against Dermatophagoides pteronyssinus.
- •-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 ?18 years and ? 60 years at the study inclusion day.
- •-Positive skin prick test with a standardized commercially available
- •preparation of Dermatophagoides pteronyssinus 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 an area at least 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 Dermatophagoides pteronyssinus (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.
- •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 last 5 years with a allergen extract of Dermatophagoides pteronyssinus or other allergenic extracts of mites that may interfere with the allergen to test due to a high degree of cross-reactivity
- •-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 or IMAOs, beta-blockers, chronic use of
- •corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
- •-Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the 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.
研究者
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