Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen

Intervention / Treatment
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* Biological: Immunotherapy with modified extract of Olea europaea pollen
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection. | Biological: Immunotherapy with modified extract of Olea europaea pollen<br>* Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.<br>|
| Placebo Comparator: 2<br>Placebo for subcutaneous injection. | Biological: Placebo<br>* Placebo for subcutaneous monthly administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and medication score |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response skin prick-test |  | 2 years | 
| Medication score |  | 2 years | 
| Rhinoconjunctivitis quality of life questionnaire |  | 2 years | 
| Visual Analog Scales (VAS) |  | 2 years | 
| Serology |  | 2 years | 
| Symptoms score |  | 2 years | 
| Exhaled nitric oxide |  | 2 years | 
| Adverse event |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis