ISRCTN99056955已完成未知
Evidence of the benefit of SYN-53 in a double-blind, placebo-controlled monocentric study in the treatment of patients with allergic rhinoconjunctivitis due to grass pollen and associated symptoms
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Persons of either sex between 18 and 65 years of age
- •2. Oral and written consent
- •3. Patients with clinically relevant sensitization to grass pollen and allergic symptoms for at least 2 years
- •4. Positive skin prick test (SPT) to grass pollen
- •5. Proven response to exposure to grass pollen in the AEC
- •6. Patients who agree to undergo all examinations and procedures mentioned in the study protocol
- •7. Patients who are fully conversant with the German language
排除标准
- •1. Persons under 18 years of age
- •2. Acute infections
- •3. Current cancer diagnosis/cancer within the last 5 years or autoimmune disease
- •4. Gastrointestinal disorders that may affect the absorption and processing of orally ingested substances, such as congenital gastrointestinal malformations or acute gastrointestinal infections
- •5. Severe forms of the following underlying chronic diseases: neurological diseases, metabolic diseases, severe asthma or respiratory obstruction, congenital anomalies of the heart, gastrointestinal system, or lungs
- •6. Patients with an FEV1 <70% (predicted value) prior to allergen exposure
- •7. Mental illnesses (e.g., depression) in the last 2 years
- •8. Eating disorders (e.g. bulimia, anorexia nervosa) in the last 2 years
- •9. Pregnant or breastfeeding female subjects
- •10. Alcohol or drug abuse
- •11. Clinically relevant hypersensitivity to any of the ingredients of SYN-53
- •12. Participation in clinical trials in the last 3 months
- •13. Placement in an institution due to court or official orders
- •14. Contraindications to epinephrine and/or other emergency medications (especially cetirizine)
- •15. Hyposensitization within the last 5 years against grass pollen
- •16. Heavy smokers (according to WHO definition more than 20 cigarettes daily)
- •17. Use of certain medications before V1 as well as during the study:
- •17.1. Decongestant nasal drops (3 days)
- •17.2. Antihistamines (5 days)
- •17.3. Anti-allergic eye drops and nasal sprays (1 week)
- •17.4. Topical steroids (2 weeks)
- •17.5. Systemic corticosteroids (3 weeks)
- •17.6. Probiotics (4 weeks)
- •17.7. Antibiotics (4 weeks)
研究者
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