Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

Exclusion Criteria

• •Acute or chronic infectious conjunctivitis
• •History of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites)
• •Patients are not allowed to enter into the study:
• •with typical symptoms against co-allergens such as tree or weed pollen, HDM, cat and dog, and other country specific allergens
• •with CAP-RAST co-allergen ≥ grass
• •* Persistent asthma, according to Global Initiative for Asthma (GINA)
• •* Acute or chronic inflammatory or infectious airways disease
• •* Chronic structural disease of the lung (e.g., emphysema or bronchiectasis)
• •* Autoimmune and/or immune deficiency
• •* Any disease that prohibits the use of adrenaline (e.g., hyperthyroidism)
• •* Severe uncontrolled disease that could increase the risk to the patients while participating in the study, including but not limited to: cardiovascular insufficiency, severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
• •* Active malignant disease during the previous 5 years
• •* Significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient
• •* Abuse of alcohol, drugs or medications within the past year
• •* Severe psychiatric, psychological or neurological disorder
• •* Immunotherapy against grass pollen within the last 5 years
• •* Systemic and/or topical treatment with β-blockers within 1 wk prior to V2
• •* Use of medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at V2
• •* Use of tranquiliser or psychoactive drugs within 1 week prior to V1
• •* Use of systemic corticosteroids within 3 months prior to V1
• •* Immunization with vaccines within 7 days prior to V2
• •* Expected non-compliance and/or no cooperation
• •* Participation in another clinical study within 30 days prior to V2
• •* Prior participation in this study
• •* Employees at the investigational centre or first degree relative or partner of the investigator
• •* Planed donation of germ cells, blood, organs or bone marrow during the course of the study
• •* Contractually not capable
• •* A positive pregnancy test at V1
• •* Jurisdictional or governmentally institutionalised.