EUCTR2014-001210-26-ES进行中（未招募）1 期
Biological standardization of allergen extracts of pollen of Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense and Poa pratensis in patients sensitized to them.
PROBELTE PHARMA S.A.0 个研究点目标入组 63 人开始时间: 2015年5月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 63
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
入选标准
- •- Positive clinical history of allergy inhalation (rhinitis and / or rhinoconjunctivitis and / or asthma) against allergen extract.
- •- Signed written informed consent.
- •- Subjects of both sexes, of every race and ethnicity.
- •- Age between18-60 years old.
- •- A positive prick test (diameter of the wheal greater or equal than 3 mm) with a standardized allergen extract commercial
- •- A positive test for specific IgE of the allergen extract in class 3 or higher blood serum
- •- Patients must live in a geographic area where the allergy caused by the allergen in question is a relevant problem.
- •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 63
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Allergen immunotheraphy in the last 5 years with a Grass pollen extract .
- •-Drugs that may interfere the cutaneous response 15 days before the study and during the study (eg, antihistamines).
- •-Patients who had received treatments with: blockers, tetraciclic or tryciclic antidepresives, IMAOS, corticosteroids chronic use of oral corticosteroids, or corticosteroids use orally or parenterally in repeated and intermittent regimens (> 10 mg / day of prednisone or equivalent).
- •-Pregnant or lactating women
- •- Dermographism, atopic dermatitis and / or urticaria that affects the skin area where the test is performed.
- •-Clinically relevant immune system diseases, both autoimmune and immunodeficiency
- •-Serious uncontrolled illness that may increase the risk to the safety of the subjects participating in this study
- •-Subjects with diseases or conditions that limit the use of adrenaline (coronary heart disease, severe hypertension, etc..).
- •-Subjects who have received anti-IgE treatment (Omalizumab).
研究者
相似试验
进行中（未招募）
不适用
Biological standardization of allergen extracts of pollen of Artemisa vulgaris and Platanus acerifolia and the acarus Dermatophagoides farinae in patients sensitized to themTreatment and diagnosis of allergy to Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae.MedDRA version: 14.1Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.1Level: LLTClassification code 10066092Term: Acaridae allergySystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.1Level: PTClassification code 10048908Term: Seasonal allergySystem Organ Class: 10021428 - Immune system disordersEUCTR2012-000672-42-ESBial Industrial Farmacéutica S.A.
进行中（未招募）
1 期
Biological standarization of pollen of Phleum pratense, Lolium perenne, Poa pratensis y Dactylis glomerata and its mixture to obtain extracts of these pollens with a potency provokes the same skin reaction in sensitive patients that the reaction the histamine produces in the subjects.Biological standarization for allergenic extracts in patients with hipersensibility to extractMedDRA version: 20.0Level: HLGTClassification code 10001708Term: Allergic conditionsSystem Organ Class: 10021428 - Immune system disordersEUCTR2019-002644-24-ESDiater, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas S.A.120
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.
进行中（未招募）
不适用
Estandarización biológica del extracto alergénico de Secale cereale para determinar la actividad biológica en unidades equivalentes de Histamina (HEP).EUCTR2010-023951-27-ESaboratorios LETI, S.L.Unipersonal30