RPCEC00000125已完成2 期
Therapeutic effect and safety of the sublingual vaccines of house-dust mites with different treatment schedules in asthmatic children sensitive to those mites (Version 1.3). - SLIT VALERGEN-Asthma-Children-Phase II
ational Center of Bioproducts (BioCen)0 个研究点目标入组 300 人开始时间: 2012年4月2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
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 5 years 至 15 years（—）
- 性别
- All
入选标准
- •1. Asthmatic allergic patients with a clinical positive history of allergic symptoms provoked by the house-dust.
- •2. It proves cutaneous positive with the allergen extracts of D. pteronyssinus or B. Tropicalis to 20 000 UB / mL Keeping in mind that the cutaneous answer for the respective allergen is predominant when compared to that obtained with other mites, the patients will be included in one of the two groups: A: D. pteronyssinus, B: B. tropicalis)
- •3. Patients clinically diagnosed as extrinsic asthmatics that, according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment.
- •4. Age between 5 and 15 years.
- •5. Any sex and color skin.
- •6. Patient whose parents or tutors express their informed consent in writing to participate in the trial.
排除标准
- •1. Patients on allergenic extract immunotherapy during the two years before.
- •2. Patients classified as intermittent or severe persistent asthmatics after being interviewed.
- •3. Patients with a diagnostic of an autoimmune disease.
- •4. Generalized severe eczema.
- •5. Patients with diagnosed tumoral disease.
- •6. Patients on betablocker treatment.
- •7. Patients with psychiatric disorders.
- •8. Patients not cooperating with treatment.
- •9. Patients who needed,at least a year before the study, immunostimulant or immunosuppressor treatment (no corticosteroids) including interferon and cyclosporine A.
- •10. Pregnancy and breastfeeding (will be perform pregnancy test to females after menarche).
- •11. Adrenalin-contraindicated patients (high blood pressure).
- •12. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.
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