Specific Immunotherapy for Allergic Child

Study Overview
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Brief Summary
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The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive potential role that could be played, in particular in the forms of allergic asthma, because this method constitute the only intervention (unlike that pharmacologic) able to act on the same causes of the disease, altering the natural history. To achieve this the investigator has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies that, with scientific rigor, have demonstrated the benefits.

Detailed Description
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The Investigator proposes to compare, in children with allergic rhinitis and / or allergic asthma to grasses, the pain caused by the administration of the Specific Immunotherapy (ITS) via epicutaneous with autoinjector (INJEX) pressure without needle vs. the traditional subcutaneous immunotherapy (SCIT).

Official Title
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Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child

Conditions
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Allergic Rhinitis, Allergic Asthma, Grass Allergy

Intervention / Treatment
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* Device: Injex
* Procedure: SCIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent from both parents / legal guardian; Of both sexes; Between the ages of 5 to 18 sensitized to grasses Awareness for grasses will be established with prick test; Rhinitis established according to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and / or stage 1 or 2 Asthma according to GINA classification (Global Initiative for Asthma) It may, or not, be going on ITS with s.c. administration Exclusion Criteria: Children under age 5 and age> 18 years; Autoimmune diseases and immunodeficiencies; Neoplasms; Severe psychological problems; Treatment with β-blockers; Poor compliance, including language training; Severe asthma uncontrolled by medication or irreversible airway obstruction (FEV1 less than 70% of the predicted value); Severe cardiovascular diseases in which may be hazardous in the administration of adrenaline

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITS with Injex<br>For Each patient, at each monthly vaccination session and randomly in alternate mode, will be administered two vaccine doses of 0.25 ml each at 20 minutes from one another in the two arms, in an alternating manner via Injex and via subcutaneous. | Device: Injex<br>* administration of Specific Immunotherapy (ITS) with car pressure injector without a needle<br>|
| Active Comparator: SCIT: ITS via subcutaneous<br>For Each patient, at each monthly vaccination session and randomly in alternate mode, will be administered two vaccine doses of 0.25 ml each at 20 minutes from one another in the two arms, in an alternating manner via Injex and via subcutaneous. | Procedure: SCIT<br>* administration of Specific Immunotherapy (ITS) via traditional subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of pain | questionnaire of the pain scale monthly at each seat vaccination soon after every administration : the Wong-Baker scale for children aged 3 to 8 years and the classical analogue scale from 8 years and 1 day to 18 years. | monthly for 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of pain | questionnaire of the pain scale monthly at each seat vaccination: the Wong-Baker scale for children aged 3 to 8 years and the classical analogue scale from 8 years and 1 day to 18 years. | 20 minutes after every administration | 
| Incidence of procedure adverse events | adverse events related to the different procedure used for the administration of the specific immunotherapy | within 24-48 hours after every administration | 
| Incidence of procedure adverse events | adverse event related to the different procedure used for the administration of the specific immunotherapy recorded by the patient on a special diary | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grass Allergy, Allergic Rhinitis, Allergic Asthma, Paediatric