NL-OMON38151已完成2 期
A multi-centre, randomized, double-blind, placebo-controlled, dose range finding study to identify the optimal (i.e. safe and effective) dose of PURETHAL® Mites SCIT in patients with house dust mites-induced persistent allergic rhinitis/rhinoconjunctivitis. - PURETHAL® Mites Dose Range Finding study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent;2. Patients (male or female) must be >= 18 and <= 60 years at screening;3. Patients with allergic rhinitis or rhinoconjunctivitis for at least 1 year; allergic symptoms related to HDM, with or without concomitant clinically stable controlled mild to moderate asthma (according to GINA classification) (Koshak, 2007) ;4. Patients with a history of concomitant asthma should have a FEV1 > 70% at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80%.;5. Positive SPT to HDM D. pter and/or D. far (mean wheal diameter >= 3mm compared to negative control and negative control should be negative, assessed within 1 year before randomization) ;6. Serum specific IgE-test (ssIgE) level for HDM D. pter or D. far at screening (> 0.7 U/ml);7. Positive TNPT for HDM D. pter extract at screening (Lebel score >= 6 at or below 10,000 AU/ml)
排除标准
- •1. Current clinically relevant symptoms of seasonal rhinitis/rhinoconjunctivitis caused by other allergen(s) than HDM (with a demonstrated positive SPT for this allergen) at the time of inclusion (to avoid interference with TNPT at inclusion);2. Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals ;3. Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years;4. Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) in the past 5 years ;5. Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period;6. Any vaccination one week before start of therapy and during the up-dosing phase ;7. Any anti-IgE therapy within the last 6 months prior to inclusion and during study ;8. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs;9. Active malignancies or any malignant disease in the past 5 years;10. A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or hematological disorders ;11. Moderate to severe nasal obstructive diseases such as polyps, septal deviations etc.;12. Clinically significant chronic sinusitis or ocular infection;13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma);14. Use of systemic corticosteroids within 4 weeks of screening;15. Treatment with systemic or local beta-blockers;16. Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study;17. Pregnancy, lactation or inadequate contraceptive measures (contraceptive measures considered as adequate include appropriate use of oral contraception, i.m. contraception or a contraceptive device);18. Alcohol, drug, or medication abuse within the past year and during study;19. Any abnormal laboratory parameter at screening that in the opinion of the investigator is considered clinically relevant;20. Lack of co-operation or compliance;21. Severe psychiatric, psychological, or neurological disorders;22. Patients who are employees of the department, 1st grade relatives, or partners of the investigator;23. Expected changes in HDM exposure during the study (avoidance measures, move, etc.)
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