MOA Study of Ze 339 in Seasonal Allergic Rhinitis

Inclusion criteria

• Allergic rhinitis since at least 2 years
• Age: = > 18 years
• Consent in accordance with the AMG (=German Drug Law)
• Positive skin test, skin prick test or positive RAST for grasses The skin prick test is positive if the wheal is >= 3 mm greater than control; a skin test is positive if the wheal is >= 7 mm greater than control
• Women of childbearing potential have to use a highly effective method of birth control (according CPMP/ICH/286/95 Note 3) during the duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

Exclusion criteria

• Past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing
• Past or current alcohol or medication dependency or abuse
• Bronchial asthma (FEV < 80 %)
• Glaucoma, cataract or ocular herpes simplex
• Clinically relevant deviations from normal laboratory parameters (if known)
• Antihistamines with a long-term effect
• Malignant diseases, including in the patient's case history
• Parasites
• Study participants who are taking part in another study or took an investigational product during the last 4 weeks before the start of treatment
• Progressive systemic diseases such as tuberculosis, leukoses, collagenoses, multiple sclerosis, Aids, HIV infection and other autoimmune diseases
• Other types of rhinitis with different causes, acute or chronic sinusitis
• Pregnancy or lactation
• Serious internal diseases, e.g. serious decompensated diseases of the heart, liver, kidneys or diabetes mellitus
• Patients with rarely occurring hereditary problems galactose-intolerance, Lapp-lactase-deficiency or glucose-galactose-malabsorption
• Pre-existing liver damage
• The use of non-steroidal antirheumatic agents (NSAR)
• Hypersensitivity towards one of the ingredients in the investigational product
• Not adhering to the following periods of abstention before the nasal provocation test: 3 days for DNCG, nedocromil, nasal and oral antihistamines, and tricyclic psychotropic drugs, 1 months systemic treatment with glucocorticoids, 14 days for nasal and topical corticosteroids, 1 week for antihistamines, and 1 day for α-adrenergic drugs. The use of ACE inhibitors or ß-blockers
• Previous organ transplants