Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

Study Overview
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Brief Summary
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The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass 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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Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Depigoid Parietaria judaica 1000DPP/ml
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent, signed by the subject Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen Patient of both gender aged from 18 up to 55 Diagnosed Sensitivity to Parietaria pollen base on: Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L - Patients who are able to comply with the dose regime Exclusion Criteria: Relevant sensitivity to another perenne allergen Patient with asthma Use of immunotherapy during the last four years Treatment with B. Blocking agents Patient suffering from some pathology in which adrenaline was contraindicated Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study Subject suffers from autoimmune disease(thyroiditis, lupus, etc.) Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance. Intolerance to aspirin Pregnant women or with pregnancy risk and brest-feeding

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>A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml. | Biological: Depigoid Parietaria judaica 1000DPP/ml<br>* Subcutaneous monthly treatment<br>* Other names: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.;|
| Placebo Comparator: 2<br> | Biological: Placebo<br>* Subcutaneous monthly treatment<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic, rhinoconjunctivitis, Immunotherapy