purethal grasses rush study

Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis

Summary: this study investigates the safety of two up-dosing regimen. the safety of purethal grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks). the primary parameter will be the proportion of patients who experience systemic reactions \> grade i within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached. it is expected that up-dosing purethal grasses according to the rush regimen is as safe as using the conventional regimen.


Eligibility criteria:
inclusion criteria * patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (fev1 \> 70%) for at least 2 years related to grass pollen, eligible for scit. * confirmation of ige-mediated allergy by means of: * positive spt to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or * specific serum ige-test (ssige \>0.7 u/ml) for grass pollen, or * positive provocation test for grass pollen. * age ≥ 18 years. * patients have given a written informed consent exclusion criteria: * chronic asthma or emphysema, particularly with a fev1 ≤ 70% of predicted value. * serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, hiv). * active inflammation/infection of the target organs (nose, eyes, lungs). * severe atopic dermatitis in need for systemic immunosuppressive medication. * symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension. * severe kidney disease. * diseases with a contra-indication for the use of adrenaline. * treatment with systemic or local beta-blockers or immunosuppressive drugs. * history of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis. * any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months. * participation in a clinical study with a new investigational drug within the last three months. * pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, iud, condom use if used together with a spermicide and having no sexual relationship with a man). * alcohol or drug abuse. * lack of co-operation or severe psychological disorders. * completed or ongoing long-term treatment with tranquilizer or psycho active drugs. * low compliance or inability to understand instructions/study documents. * completed or ongoing treatment with anti-ige-antibody. * patients being in relationship or dependence with the sponsor or investigator. * allergy to any of the excipients. * severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.

Keywords: immunotherapy grass pollen seasonal allergy dose tolerability