NCT01591343终止2 期
Prospective Study to Evaluate the Safety of a 4-month Treatment With Depigoid® Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml) in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Mild Persistent or Intermittent Asthma
Laboratorios Leti, S.L.20 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 20
- 主要终点
- Primary variable
研究概览
简要总结
Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma.
Primary variable: number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
详细描述
Investigator(s):
Approximately 10 study centers (allergy services) in Spain
Planned study period:
MAY 2012 (first subject in) - MAR 2013 (last subject out)
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 55 years of age (both inclusive).
- •Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose less or equal to 400 µg/day budesonide or an equivalent -- caused by a clinically relevant sensitization to house dust mites (Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae).
- •The IgE-mediated sensitization will be demonstrated by means of the following: medical history and IgE specific to house dust mites (D. pteronyssinus or D. pteronyssinus and D. farinae) CAP RAST ≥ 2 and positive skin prick test. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
- •Asthmatic patients must be stable and on a stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study.
排除标准
- •Any contraindication for treatment with allergen specific immunotherapy.
- •Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value < 80% of the predicted normal value.
- •Allergy symptoms due to sensitization to pollens or other perennial allergens (molds, epithelia).
- •Subjects with typical symptoms to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelial cells cannot participate in this study. Patients sensitized to pollens with specific IgE CAP RAST < 2 can be included in this study provided that they do not present symptoms as a consequence of this sensitization. Patients sensitized to animal epithelia who do not present symptoms can participate in this study provided that they are not exposed to the allergen to which they are sensitized, even though they present specific IgE with CAP RAST ≥
- •If they were exposed to the animal in question, these subjects must have a specific IgE with CAP RAST < 2 in order to participate in the study.
- •Asthma requiring a dose > 400 µg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists, to reach control according to the Global Initiative for Asthma (GINA 2010).
- •Patients with non controlled bronchial asthma within 3 months prior to Visit
- •Patients with asthma who have been treated with systemic steroids within 3 months prior to V
- •Patients with hospital admission due to asthma exacerbations within 1 year prior to V1
- •Acute or chronic inflammatory or infectious diseases of the airways.
- •Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
- •Immune system diseases, both autoimmune diseases and immunodeficiency.
- •Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism).
- •Serious uncontrolled diseases involving a risk for the subjects participating in this study, including the following for example: heart failure, serious or uncontrolled respiratory diseases, endocrine diseases, clinically relevant liver or kidney diseases or hematological diseases.
- •Malignant disease with activity in the last 5 years.
- •Clinically significant anomaly in laboratory parameters or vital signs which could involve a risk increase for the subject.
- •Excessive consumption of alcohol, drugs or medication in the preceding year.
- •Serious psychiatric, psychological or neurological disorders.
- •Use of immunotherapy with allergenic extracts of storage or house dust mites in the last 5 years.
- •Systemic or topical treatment with beta-blocker drugs.
- •Treatment with substances interfering with the immune system 2 weeks before visit
- •Use of psychotropic or antidepressants substances.
- •Use of systemic corticosteroids 3 months before visit
- •Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit
- •(Prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after immunotherapy and the next immunotherapy dose is administered at least 14 days later).
- •Participation of the subject in another clinical trial 30 days before visit
- •Subjects who have already participated in this clinical trial.
- •Subjects who are going to donate stem cells, blood, organs or bone marrow in the course of the study.
- •Female subjects who are pregnant or nursing and women with a positive pregnancy test at visit 1 or
- •Women of childbearing potential not using highly effective methods of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- •No written informed consent upon enrolment.
- •Not willing to give consent for transmission of personal "pseudonymised" data.
- •Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
研究组 & 干预措施
Depigoid® (500 DPP/ml)
Experimental
Patients will receive either Depigoid® Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), depending on their sensitization to one or both mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae).
干预措施: Depigoid® (500 DPP/ml) (Biological)
结局指标
主要结局
Primary variable
时间窗: 4 months
Number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
次要结局
- Secondary variables(4 months)
研究者
研究点 (20)
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