Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)

Study Overview
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Brief Summary
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The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis

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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Prospective, Randomised, Double Blind, Placebo Controlled Study of Treatment With Sublingual Immunotherapy of Depigmented and Polymerised Allergen Extract of O. Europaea in Two Groups of Patients With Allergic Rhinitis /Rhinoconjunctivitis

Conditions
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Allergy, Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Immunotherapy with modified extract of O. europaea pollen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis Patients of both gender > 18 years old Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2) Specific IgE to Olea europaea Written informed consent Exclusion Criteria: Use of immunotherapy during the last four years. Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria: Treatment with ß-blockers Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role Patients suffering from immune deficiencies Patients with serious psychiatric / psychological disturbances In addition, the following was considered as exclusion criteria: Pregnant or/ in lactation patients Patients aspirin intolerance

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: A<br>Biological Vaccine | Biological: Immunotherapy with modified extract of O. europaea pollen<br>* Sublingual (2 drops daily during 2 months)<br>|
| Placebo Comparator: B<br> | Biological: Immunotherapy with modified extract of O. europaea pollen<br>* Sublingual (2 drops daily during 2 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response skin prick-test |  | 1 year | 
| Medication score |  | 1 year | 
| Rhinoconjunctivitis quality of life questionnaire |  | 1 year | 
| Analogical visual scale |  | 1 year | 
| Serology |  | 1 year | 
| Record of adverse events |  | 1 year | 

 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