Specific Immunotherapy for Allergic Child

NCT02965612 | Unknown

• 1 other identifier: 947_OPBG_2014
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Allergic Asthma; Grass Allergy

Keywords

Grass Allergy; Allergic Rhinitis; Allergic Asthma; Paediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• prevalence of pain

  20 minutes after every administration

• Incidence of procedure adverse events

  within 24-48 hours after every administration

• Incidence of procedure adverse events

  6 month

Study Arms (2)

ITS with Injex

EXPERIMENTAL

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

SCIT: ITS via subcutaneous

ACTIVE COMPARATOR

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

Interventions

Injex DEVICE

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

ITS with Injex

SCIT PROCEDURE

administration of Specific Immunotherapy (ITS) via traditional subcutaneous

SCIT: ITS via subcutaneous

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mariella Enoc: lead
• Bial Aristegui Italia srl: collaborator
• OPBG Contract and Research Organization: collaborator

Study Sites (1)

Operating unit of Allergology

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alessandro Fiocchi

  Bambino Gesù Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Fiocchi

CONTACT

0039 06.6859.; agiovanni.fiocchi@opbg.net

Chiara Mennini

CONTACT

0039 06.6859.; chiara.mennini@opbg.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 17, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 17, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)