Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass 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 the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense 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 in an up-dosing cluster regimen for 4 weeks.

Official Title
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Clinical, Multi-centre,Randomized, Double-blind, Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerised Extract of Phleum Pratense Pollen on Patients With Hypersensitivity to Grass Pollen

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Biological: Allergen extract (Phleum pratense)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent, signed by the subject. Clinical History of moderate to severe rhinitis/rhinoconjunctivitis lasting for at least 2 consecutive years, with or without episodic asthma, caused by allergy to grass pollen. Patient of both gender aged from 18 up to 55 Symptoms that coincide with allergy to grass pollen Sensitivity to grass pollen, diagnosed through a positive skin reaction to Phleum pratense: Positive prick test and /or Specific IgE to P.pratense >0,7KU/L Patients included must be mono-sensitised or, in the case of poly-sensitisation, sensitivity to p.pratense pollen should be considered as the only relevant aspect of their condition from the clinical standpoint. Patients who are able to comply with the dose regime Exclusion Criteria: Patient with mild Rhinitis/rhinoconjunctivitis Relevant sensitivity to another perennial allergen Use of immunotherapy during the last four years Treatment with B. Blocking agents Patient suffering from some pathology in which adrenalin 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 and significant psychiatric disorders. Intolerance to aspirin Pregnant women or with pregnancy risk and breast-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: Depigoid Phleum pratense 1000DPP/Ml<br>Depigmented and Polymerized Allergen extract of Phleum Pratense.Subcutaneous Immunotherapy in an up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. | Biological: Allergen extract (Phleum pratense)<br>* Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.<br>|
| Placebo Comparator: 2<br>Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years | 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 and medication score recorded by subjects |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal provocation test, Dose-response skin prick test, Rhinoconjunctivitis Quality of life questionnaire, visual scales, asthma symptom scores, medication scores, adverse event and severity adverse event, unplanned health care resource utilization |  | 2 | 

 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