PURETHAL Grasses Rush Study

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.