RPCEC00000301尚未招募2 期
Diagnostic efficacy of the nasal provocation test in patients with allergic rhinitis sensitive to house dust mites.
ational Center of Bioproducts (BioCen)0 个研究点目标入组 300 人开始时间: 2019年4月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
- Non-randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Diagnostic
入排标准
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- All
入选标准
- •Allergic group (Group A):
- •1) Patients with a positive clinical history of persistent allergic rhinitis to home dust, according to the diagnostic criteria.
- •2) Age between 18 and 50 years.
- •3) Patients with a skin prick test with allergen extracts investigated (VALERGEN-DP, VALERGEN-DS and VALERGEN-BT 20 000 UB/ mL), negative (diameter of wheal <3 mm).
- •4) People of any sex who express their informed consent in writing to participate in the study.
- •5) Negative nasal discharge.
- •6) Physical Examination of anterior nostril negative for allergic rhinitis.
- •- Non-allergic group (Group B):
- •1) Non-allergic subjects without a positive clinical history of persistent allergic rhinitis to house dust, according to the diagnostic criteria described.
- •2) Age between 18 and 50 years.
- •3) Non-allergic individuals with a skin prick test with allergen extracts investigated (VALERGEN-DP, VALERGEN-DS and VALERGEN-BT at 20,000 UB/mL), negative (wheal diameter <3 mm).
- •4) People of any sex who express their informed consent in writing to participate in the study.
- •5) Negative nasal discharge.
- •6) Physical Examination of anterior nostril negative for allergic rhinitis.
排除标准
- •1) Patients treated by Immunotherapy with allergenic extracts of D. pteronyssinus, D. siboney, D. farinae, B. tropical or home dust in the last two years.
- •2) Patients with symptoms of asthma, otitis media with effusion, acute sinusitis, rhinitis or conjunctivitis at the time of the tests.
- •3) Current use of drugs that interfere with the cutaneous and nasal reaction of the tests to be performed, which must be previously suspended.
- •4) Dermographism, atopic dermatitis in the area of skin test and urticaria.
- •5) Patients who do not express their written consent to participate in the study.
研究者
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