NCT01984541已完成2 期
Biological Standardization of Artemisia Vulgaris 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3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 objective of this study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP).
详细描述
This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive clinical history of inhalatory allergy to Artemisia vulgaris. Subject has provided written informed consent, appropriately signed and dated by the subject.
- •Subject can be male or female of any race and ethinic group. Age major or equal 18 years and ninor or equal 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.
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).
- •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. 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: 15-20 min after aplication
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Determination of Biological Activity of Three Allergen ExtractsHypersensitivityNCT02474836Roxall Medicina España S.A176
进行中（未招募）
不适用
To determine the minimum amount of Artemisia vulgaris allergen extract producing a positive skin reaction.Allergy to Artermisia vulgarisMedDRA version: 14.1Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 100000004870EUCTR2013-001310-15-ESABORATORIOS LETI, S.L.
已完成
2 期
Biological Standardization of Platanus Acerifolia Allergen ExtractAllergy to Platanus AcerifoliaNCT01739322Laboratorios Leti, S.L.36
已完成
2 期
Biological Standardization of Blomia Tropicalis Allergen ExtractAllergy to MitesNCT01597752Laboratorios Leti, S.L.20
已完成
2 期
To Determine the Minimum Amount of Alternaria Alternata Allergen Extract Producing a Positive Skin Reaction.Allergy to Alternaria FungusNCT01984528Laboratorios Leti, S.L.30