Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen

The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo-controlled study with two arms of treatment: placebo and active.

Inclusion Criteria:

• Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
• Patients of both gender aged from 18 and 55 years
• Patient's perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
• FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
• Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against Olea europaea pollen. The IgE mediated sensitization has to be verified by:
• Suggestive medical history
• Specific IgE against Olea europaea pollen CAP RAST ≥0.7Ku/l
• Positive skin prick test (SPT) to grass Olea pollen resulting in a wheal diameter of at least 3 mm.

Exclusion Criteria

• History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
• Participation in an immunotherapy with comparable extracts within the last five years.
• Treatment with β-blocker
• Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
• Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
• Immunopathological diseases
• Patients who are expected to be non-compliant and/or not co-operative
• Women, where pregnancy is defined as the state of a female after conception and until the termination of gestation