Specific Immunotherapy for Allergic Child

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

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Rhinitis; Allergic Asthma; Grass Allergy
• Intervention / Treatment: Device: Injex; Procedure: SCIT

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • Operating unit of Allergology
    • Contact: Alessandro Fiocchi; Phone Number: 4777-3570 0039 06.6859.; Email: agiovanni.fiocchi@opbg.net
    • Contact: Carmelo Pantaleo; Phone Number: 3899 +39 06 6859; Email: carmelo.pantaleo@opbg.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITS with 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.	Device: Injex; administration of Specific Immunotherapy (ITS) with car pressure injector without a needle
Active Comparator: SCIT: ITS via subcutaneous; 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; administration of Specific Immunotherapy (ITS) via traditional subcutaneous

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mariella Enoc
• Collaborators: Bial Aristegui Italia srl; OPBG Contract and Research Organization
• Investigators: Principal Investigator: Alessandro Fiocchi, Bambino Gesù Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Allergic Asthma; Paediatric; Grass Allergy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 947_OPBG_2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO