comparison of different up-dosing schedules with osiris phleum pratense

Conditions: Rhino-conjunctivitis

Summary: the purpose of this trial is to investigate the tolerability of osiris phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.


Eligibility 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)

Keywords: grass pollen induced allergic rhinoconjunctivitis