SUBLIVAC® study on the safety of an initial phase rush-in with the use of a compliance friendly one bottle concept. - SUBLIVAC® SPRINT study

HAL Allergy BV0 个研究点目标入组 450 人开始时间: 2005年12月12日最近更新: 2013年4月22日

试验速览

暂无简介。

•·Subject selected to be treated with SLIT.
•·Male or female, age ³ 18 years.
•·Subject with rhinitis or rhinoconjunctivitis
•·The allergy should be confirmed by, for example, a positive SPT (mean wheal diameter > 3 mm) or specific serum IgE-test (RAST = 2).
•·Subject must be willing to follow all study procedures including attendance at practise for scheduled study visits and compliance with study treatment regimen.
•·Subject must give a written informed consent (IC).
•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) yes
•F.1.3.1 Number of subjects for this age range

•·Chronic asthma or emphysema, particularly with a FEV1 < 70% of predicted value.
•·Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis).
•·Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension.
•·Diseases with a contra-indication for the use of adrenaline.
•·Severe kidney disease.
•·Use of systemic steroids.
•·Treatment with ß-blockers or ACE inhibitors or immunosuppressive drugs.
•·Active infection of the target organ.
•·Severe atopic dermatitis.
•·Participation in a clinical study with a new investigational drug within 3 months prior to enrolment.
•·Pregnancy, lactation or inadequate contraceptive measures.
•·Alcohol- or drug abuse.
•·Lack of co-operation or severe psychological disorders.
•·Other serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the trial.

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