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Specific Immunotherapy for Allergic Child

Primary Purpose

Allergic Rhinitis, Allergic Asthma, Grass Allergy

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Injex
SCIT
Sponsored by
Mariella Enoc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Grass Allergy, Allergic Rhinitis, Allergic Asthma, Paediatric

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Operating unit of AllergologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ITS with Injex

SCIT: ITS via subcutaneous

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of procedure adverse events
adverse events related to the different procedure used for the administration of the specific immunotherapy
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

Full Information

First Posted
November 8, 2016
Last Updated
November 14, 2016
Sponsor
Mariella Enoc
Collaborators
Bial Aristegui Italia srl, OPBG Contract and Research Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02965612
Brief Title
Specific Immunotherapy for Allergic Child
Official Title
Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mariella Enoc
Collaborators
Bial Aristegui Italia srl, OPBG Contract and Research Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Asthma, Grass Allergy
Keywords
Grass Allergy, Allergic Rhinitis, Allergic Asthma, Paediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ITS with Injex
Arm Type
Experimental
Arm 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.
Arm Title
SCIT: ITS via subcutaneous
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Injex
Intervention Description
administration of Specific Immunotherapy (ITS) with car pressure injector without a needle
Intervention Type
Procedure
Intervention Name(s)
SCIT
Intervention Description
administration of Specific Immunotherapy (ITS) via traditional subcutaneous
Primary Outcome Measure Information:
Title
prevalence of pain
Description
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.
Time Frame
monthly for 6 month
Secondary Outcome Measure Information:
Title
prevalence of pain
Description
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.
Time Frame
20 minutes after every administration
Title
Incidence of procedure adverse events
Description
adverse events related to the different procedure used for the administration of the specific immunotherapy
Time Frame
within 24-48 hours after every administration
Title
Incidence of procedure adverse events
Description
adverse event related to the different procedure used for the administration of the specific immunotherapy recorded by the patient on a special diary
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Fiocchi
Phone
0039 06.6859.
Ext
4777-3570
Email
agiovanni.fiocchi@opbg.net
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Mennini
Phone
0039 06.6859.
Ext
2572
Email
chiara.mennini@opbg.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Fiocchi
Organizational Affiliation
Bambino Gesù Hospital and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Operating unit of Allergology
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Fiocchi
Phone
0039 06.6859.
Ext
4777-3570
Email
agiovanni.fiocchi@opbg.net
First Name & Middle Initial & Last Name & Degree
Carmelo Pantaleo
Phone
+39 06 6859
Ext
3899
Email
carmelo.pantaleo@opbg.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Specific Immunotherapy for Allergic Child

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