In vivo biological standardization of Olea europaea allergen extracts.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
研究概览
简要总结
Biological standardization of the allergenic extract of Olea europaea
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient residing in a geographic area where Olea europaea is prevalent
- •Age between 18 and 50 years, regardless of gender.
- •Patient diagnosed with IgE-mediated allergy to the Olea europaea allergen, meeting both of the following criteria:
- •Positive skin prick test to the allergen, with a wheal whose mean diameter is at least ≥ 3 mm greater than that produced by the negative control included in the diagnostic panel.
- •Positive specific IgE (in vitro diagnostic test) to the allergen, class 1 or higher.
- •Mean wheal diameter ≥ 4 mm induced by a 10 mg/mL histamine dihydrochloride solution (positive control).
- •The patient must be capable of understanding the purpose and scope of the study and must have signed the informed consent form to participate.
排除标准
- •The patient has received specific allergen immunotherapy with the extract to be standardized and/or with other allergen(s) that may interfere with the skin reactivity to the extract being standardized (cross-reactivity/homologous groups) within the past 5 years.
- •Use of medications that may interfere with the results of the skin prick test (SPT), including antihistamines (H1 and H2 receptor antagonists) or cromolyn sodium, and that cannot be discontinued prior to skin testing.
- •Presence of lesions or tattoos on the skin area where the tests are to be performed, which at the time of testing may interfere with accurate assessment.
- •Any condition that may alter the patient’s response to the SPT, such as: pregnancy (in case of suspicion, a pregnancy test should be performed), breastfeeding, dermographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests are to be conducted for standardization.
- •Inability of the patient to understand the purpose or objectives of the study.
- •Inability or refusal of the patient to sign the informed consent to participate in the study.
- •Hypersensitivity to any of the excipients included in the investigational product.
- •Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, as well as chronic treatment with tricyclic antidepressants and/or systemic corticosteroids (excluding inhaled corticosteroids).
结局指标
主要结局
The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.
Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.
Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml
Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml
次要结局
- Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study
研究者
FLAVIA TAMARA HERNÁNDEZ
Scientific
Asac Pharmaceutical Inmunology S.A.