Mechanistic study assessing the immunological response of subjects after treatment with different formulations of sublingual immunotherapy. - Assessing the immunological response after sublingual immunotherapy

Imperial College London0 个研究点目标入组 30 人开始时间: 2012年1月23日最近更新: 2020年10月13日

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•Male and female 18-65 years of age
•Written informed consent obtained before entering the trial
•A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
•A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season
•Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm) to Phleum pratense
•Positive specific IgE against Phleum pratense (= IgE Class 2)
•Physical examination with no clinically relevant findings
•If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial
•Willingness to comply with this protocol
•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) no
•F.1.3.1 Number of subjects for this age range

•A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of – and potentially overlapping - the grass pollen season
•A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed
•History of emergency visit or admission for asthma in the previous 12 months
•Use of an investigational drug within 30 days prior to screening
•Previous treatment by immunotherapy with grass pollen allergen within the previous 10 years
•History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
•History of angioedema
•Any of the following underlying conditions known or suspected to be present:
•Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alcoholism
•Ischemic heart disease or angina requiring current daily medication
•Or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease)
•Immunosuppressive treatment

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