Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Written informed consent obtained before entering the trial
Male or female >/= 18 years at visit 1
A clinically relevant history of grass pollen induced allergic rhinoconjunctivitis (moderate to severe) and having received symptomatic treatment during grass pollen season 2010 and 2011
Positive skin prick test response (wheal diameter >/= 3mm) to Phleum pratense
Positive specific IgE against Phleum pratense (>/= 0,70KUL / class 2)
Female subjects of childbearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive methods until Visit 4
Subjects willing and able to comply with trial protocol regimen

Exclusion Criteria:

Subjects included in another protocol (treatment intervention and/or investigational medicine product) or having participated in another clinical trial within 30 days prior to visit 1
A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen (e.g. hazel, alder, birch, ash) to which the subject will be exposed during the 30-day treatment period.
A clinically relevant medical history of symptomatic perennial allergy to allergen(s) to which the subject is regularly exposed (e.g. cat, house dust mites).
Known sensitization (history of positive SPT) to food allergens with oral allergy syndrome
Uncontrolled asthma (in accordance with GINA guidelines) within the last 12 months
FEV < 60% of predicted within the last 12 months
Severe asthma exacerbation(s) within the last 12 months
A clinically relevant chronic disease (>/= 3 months) (e.g fibrosis, malignancy, type 1 diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency)
Malignancy or systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease or immune deficiency disease)
Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis or dental extraction at randomisation
Medical history of recurrent urticaria or atopic dermatitis during the last 2 years
Currently receiving treatment preventing the initiation of SIT (e.g. tricyclic antidepressants, mono amine oxidase inhibitors (MAOIs) and catechol-O-methyl transferase inhibitors (COMT inhibitors))
History of allergy, hypersensitivity, or intolerance to the excipients of the investigational medicinal product
Being immediate family of the investigator or trial staff, defined as the investigator's / staff's spouse, parent, grandparent, child or grandchild
History of drug induced (incl. immunotherapy) facial angioedema (including experience of Quincke oedema) or a family (parents or siblings) history of hereditary angioedema
Anticipated use of any prohibited medication within the specified time windows as defined in the protocol
Previous treatment by immunotherapy with grass pollen for more than one month within the last 5 years
Any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the trial evaluations or optimal participation
History of anaphylaxis with cardio respiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction)