Specific Immunotherapy for Allergic Child

Mariella Enoc36 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Allergic Rhinitis Allergic Asthma Grass Allergy

Interventions

InjexDEVICE

administration of Specific Immunotherapy (ITS) with car pressure injector without a needle

SCITPROCEDURE

administration of Specific Immunotherapy (ITS) via traditional subcutaneous

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Operating unit of Allergology

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: monthly for 6 month

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 6 month

Central Contacts

Alessandro Fiocchi

CONTACT

0039 06.6859.agiovanni.fiocchi@opbg.net

Chiara Mennini

CONTACT

0039 06.6859.chiara.mennini@opbg.net

Data from ClinicalTrials.gov

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