EUCTR2005-001584-66-DE进行中（未招募）不适用
A randomised controlled multicentre study for the safety of Depigoid(R)rush schedule
ETI Pharma GmbH0 个研究点目标入组 320 人开始时间: 2005年7月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •1. Patients of both gender aged from 18 up to 65 years
- •2. Prior to study specific examinations the patient has to give his/her written in-formed consent.
- •3. FEV1 or PEF > 70% of predicted normal value under normal conditions
- •4. FEV1 or PEF > 80% of predicted normal value directly before injection
- •5. The patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis without uncontrolled allergic asthma) caused by clinical sensitisation against tree pollen, grass pollen or house dust mites. Polysensitised patients can also be included. The IgE mediated sensitisation has to be verified by
- •· suggestive medical history
- •· a positive skin prick test LETI for tree pollen, grass pollen or house dust mites, resulting in a wheal diameter of at least 3 mm > negative control re-action or '++' versus histamine
- •· specific IgE > 1 (CAP-RAST)
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or lactating women
- •2. Women of child-bearing age not employing sufficient contraceptive protection (contraceptive medication or condom)
- •3. Participation in another clinical trial within the last 3 months prior to this study
- •4. Smokers with a manifested bronchopathy
- •5. Alcohol- or drug abusers
- •6. Persons, who are obviously not compliant
- •7. Patients, who are employees at the investigational site, relative or spouse of the investigator
- •8. Acute and chronic inflammatory or infectious diseases (incl. target organ)
- •9. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
- •10. Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- •11. Immune deficiencies
- •12. Chronic asthma
- •13. Treatment with b-blockers
- •14. Malignancies < 5 years
- •15. Any disease which prohibits the use of adrenaline (e. g. hyperthyroidism)
- •16. Serious psychiatric/psychological disturbances
- •17. Concomitant treatment with substances interfering with the immune system
研究者
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