A prospective, randomized, open, multi-centre study to assess safety of PURETHAL Birch given with a rush up-dosing regimen to patients with allergic rhinitis/rhinoconjunctivitis.

HAL Allergy B.V.0 个研究点目标入组 120 人开始时间: 2013年6月5日最近更新: 2014年6月2日

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: 120

研究概览入排标准研究者记录与标识符相似试验

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.Age =12 years.
•3.Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
•4.FEV1>70% for patients with a history of mild to moderate asthma, FEV1>70% or PEF>80% for patients without a history of asthma
•5.A positive SPT (mean wheal diameter = 3mm compared to negative control and negative control should be negative) for birch pollen.
•6.Positive serum specific anti-birch IgE-test (>0.7 U/ml) within 1 year before randomization
•and/or a positive provocation test for birch pollen within 1 year before randomization.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 64
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

排除标准

•1.Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
•2.Any specific immunotherapy (SCIT or SLIT) during the study period
•3.Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
•4.Active malignancies or any malignant disease within the past 5 years
•5.Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders
•6.Acute/active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study
•7.Secondary changes of the target organ (emphysema, bronchi-ectasia and others)
•8.Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
•9.Use of systemic steroids within 4 weeks before start of the study and during the study
•10.Treatment with systemic and local ß-blockers
•11.Vaccination within one week before start of therapy or during the initiation phase
•12.Anti-IgE therapy within the 6 months prior to inclusion and during the study
•13.Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
•14.Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device in combination with a spermicide or –pill)
•15.Alcohol, drug or medication abuse within the past year
•16.Any clinically significant abnormal laboratory parameter at screening
•17.Lack or expected lack of cooperation or compliance
•18.Severe psychiatric, psychological, or neurological disorders
•19.Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator

研究者

发起方

HAL Allergy B.V.

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