Specific Immunotherapy for Allergic Child

Mariella Enoc

Status: Unknown

Conditions: Allergic Rhinitis; Allergic Asthma; Grass Allergy

Treatments: Device: Injex; Procedure: SCIT

Study type: Interventional

Funder types: Other

Identifiers

NCT02965612

947_OPBG_2014

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 36 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

ITS with Injex

Experimental group

Description:

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.

Treatment:

Device: Injex

SCIT: ITS via subcutaneous

Active Comparator group

Description:

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.

Treatment:

Procedure: SCIT