Specific Immunotherapy for Allergic Child

Not Applicable

• Conditions: Allergic Asthma; Allergic Rhinitis; Grass Allergy
• Interventions: Procedure: SCIT; Device: Injex

• Registration Number: NCT02965612
• Lead Sponsor: Mariella Enoc

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Status Verified: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-14
• Last Update Submitted: 2016-11-14
• Study First Posted: 2016-11-17
• Last Update Posted: 2016-11-17
• Primary Completion: 2016-12
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SCIT: ITS via subcutaneous	SCIT	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.
ITS with Injex	Injex	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.

Primary Outcome Measures

Name	Time	Method
prevalence of pain	monthly for 6 month	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of procedure adverse events	6 month	adverse event related to the different procedure used for the administration of the specific immunotherapy recorded by the patient on a special diary
prevalence of pain	20 minutes after every administration	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.

Trial Locations

Locations (1)

Operating unit of Allergology; 🇮🇹 Rome, Italy