RPCEC00000127暂停2 期
Clinical trial with allergenic extracts Dermatophagoides pteronyssinus (VALERGEN-DP) and Blomia tropicalis (VALERGEN-BT) by subcutaneous therapeutic use in sensitized asthmatic adults. Version 04.” - SCIT-C-VALERGEN-DP-BT-Asthma-Adults-Phase II
ational Center of Bioproducts (BIOCEN)0 个研究点目标入组 120 人开始时间: 2012年4月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 120
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
- 16 years 至 45 years（—）
- 性别
- All
入选标准
- •1. Asthmatic allergic patients with positive responses during the preliminary survey in the following aspects: family and personal history of atopy, clinical symptoms only triggered when exposed to dust at home, mainly indoors, when getting up in the morning or going to bed at night.
- •2. Skin test positive with similar diameter (difference not mayor of 2 mm) to allergenic extracts of D. pteronyssinus and B. tropicalis, VALERGEN, 20,000 BU/ml.
- •3. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, according the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Consensus on Asthma Diagnosis and Treatment (GINA).
- •4. Age between 16 and 45 years.
- •5. Any sex and color skin.
- •6. Patients expressing their consent in writing to participate in clinical trial.
排除标准
- •1. Patients on allergenic extract immunotherapy during the two preceding years.
- •2. Patients classified as intermittent or severe persistent asthmatics after being interviewed.
- •3. Patients with a diagnosed autoimmune disease of any kind.
- •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, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A.
- •10. Pregnancy and breastfeeding.
- •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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