NCT01984528已完成2 期
Biological Standardization of Alternaria Alternata Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).
Laboratorios Leti, S.L.4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
研究概览
简要总结
The objetive of this study is to determine the minimum amount of Alternaria alternata allergen extract producing in a positive skin reaction.
详细描述
This is an open, unblinded and non-randomized biological assay. The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive clinical history of inhalatory allergy to Alternaria alternata. Subject has provided written informed consent, appropriately signed and dated by the subject.
- •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 mm
- •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.
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). 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
- •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 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).
结局指标
主要结局
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
时间窗: Test sited chould be inspected and recorded 15-20 min after appliction
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
不适用
To determine the minimum amount of Alternaria alternata allergenextract producing a positive skin reaction.Allergy to Alternaria alternataEUCTR2013-001308-13-ESABORATORIOS LETI S.L.
进行中（未招募）
1 期
Biological standardization of allergenic extracts of Platanus acerifolia, Salsola kali, Chenopodium album y Artemisia vulgarisBiological standardization for allergenic extracts in patients withhipersensibility to extracts.MedDRA version: 18.0Level: HLGTClassification code 10001708Term: Allergic conditionsSystem Organ Class: 10021428 - Immune system disordersEUCTR2013-003892-36-ESINMUNAL SA100
进行中（未招募）
不适用
Biological standardization of allergenic extracts of Dermatophagoides farinae and Lolium perenne.EUCTR2013-003270-28-ESInstituto de Inmunología y Alergia INMUNAL S.A..U.
已完成
2 期
To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.Allergy to PollenNCT01984541Laboratorios Leti, S.L.30
已完成
2 期
Biological Standardization of Platanus Acerifolia Allergen ExtractAllergy to Platanus AcerifoliaNCT01739322Laboratorios Leti, S.L.36