Twin SUBLIVAC® Grasses Clinical Efficay Study

HAL Allergy BV0 个研究点目标入组 210 人开始时间: 2006年5月10日最近更新: 2012年3月19日

试验速览

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•Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 = 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen
•Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the previous years)
•A positive skin prick test (>3 mm) and specific serum IgE-test (>1 U/ml) for grass (Lolium perenne, Phleum pratense and Poa pratensis).
•Age 12 years or older.
•Subjects shall give a written informed consent
•Are the trial subjects under 18? yes
•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

•A positive SPT for perennial allergens of house dust mite and moulds
•Allergy to any of the excipients
•Symptoms related to concomitant sensitisation to perennial allergens of pets
•Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
•Use of symptomatic medication, including corticosteroids (systemic and local) outside tree and grass pollen season
•Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
•Inflammation and infection of the target organ
•Severe atopic dermatitis requiring systemic immuno-suppressive medication
•Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
•History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
•Pregnancy, lactation or inadequate contraceptive measures
•Alcohol- or drug abuse
•Lack of co-operation or severe psychological disorders

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