EUCTR2011-002296-42-DE进行中（未招募）1 期
Phase II study to assess the tolerability, safety and efficacy ofsubcutaneous cluster-immunotherapy in patients suffering from birchpollen allergy - Phase II study of birch SCIT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
- 性别
- All
入选标准
- •Signed and dated patient’s informed consent form obtained prior to any study specific examination
- •Female or male patients, 18-65 years of age at the time of signing the informed consent form
- •Allergic rhinitis/ rhinoconjunctivitis due to birch pollen for at least two years, with or without well controlled asthma defined in GINA guideline (Global Initiative for Asthma, 2017)
- •Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value for patients with a history of asthma
- •Sensitization to birch pollen, verified by:
- •-positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and
- •positive (histamine) control = 3 mm) and
- •-Serum allergen-specific IgE to birch = 0.7 kU/L (CAP EAST class = 2) and
- •-positive response to nasal provocation with birch pollen allergen extract (at least at the fourth concentration step)
- •Assumed compliance and ability of the patient to follow the instructions of the study staff.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Previous immunotherapy with tree pollen allergen extracts according to the homologous group of tree pollen of the birch group” / fagales group”, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within the last 5 years
- •Simultaneous participation in other clinical trials
- •Simultaneous specific immunotherapy with other allergens
- •Usual contraindications for SCIT
- •Usual contraindications for NPT
- •History of anaphylaxis
- •Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
- •Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017)
- •Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
- •Completed or ongoing treatment with anti-IgE-antibodies
- •Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
- •Severe acute or chronic inflammatory or infectious diseases
- •Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
- •Systemic and local (eye drops) treatment with beta-blockers
- •Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)
- •Relationship or dependence with the sponsor and/or investigator
研究者
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