EUCTR2011-000393-61-NL进行中（未招募）1 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 in patients with persistent allergic rhinitis/rhinoconjunct
HAL Allergy B.V.0 个研究点目标入组 290 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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.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)
- •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 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 ?-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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