NCT01407835已完成2 期
Biological Standardization of Dactylis Glomerata Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
Laboratorios Leti, S.L.4 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年10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
- 31
- 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 biologic activity of a Dactylis glomerata allergen extract in histamine equivalent prick (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. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Dactylis glomerata 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
- Non Randomized
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Dactylis glomerata.
- •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 < 50 years at the study inclusion day.
- •Positive skin prick test with a standardized commercially available preparation of Dactylis glomerata allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. 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 Dactylis glomerata(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
- •Allergic symptoms during the pollen season of Dactylis glomerata.
- •Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 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 (e.g., grass group extracts).
- •Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
- •Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).
- •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.
- •Participation in another clinical trial within the last month.
- •Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,..)
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 sites should be inspected and recorded 15-20 min after application
次要结局
未报告次要终点
研究者
研究点 (4)
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