Specific Immunotherapy for Allergic Child

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965612
• Other study ID #: 947_OPBG_2014
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 14, 2016
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: November 2016
• Source: Bambino Gesù Hospital and Research Institute
• Contact: Alessandro Fiocchi
• Phone: 0039 06.6859.
• Email: agiovanni.fiocchi[@]opbg.net
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 ß-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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis
• Grass Allergy
• Rhinitis
• Rhinitis, Allergic

Intervention

Device:
• Injex
administration of Specific Immunotherapy (ITS) with car pressure injector without a needle

Procedure:
• SCIT
administration of Specific Immunotherapy (ITS) via traditional subcutaneous

Locations

Country	Name	City	State
Italy	Operating unit of Allergology	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Mariella Enoc	Bial Aristegui Italia srl, OPBG Contract and Research Organization

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes