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Specific Immunotherapy for Allergic Child

NCT ID: NCT02965612

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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).

Conditions

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Allergic Rhinitis Allergic Asthma Grass Allergy

Keywords

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Grass Allergy Allergic Rhinitis Allergic Asthma Paediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Injex

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

SCIT

Intervention Type PROCEDURE

administration of Specific Immunotherapy (ITS) via traditional subcutaneous

Interventions

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Injex

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

Intervention Type DEVICE

SCIT

administration of Specific Immunotherapy (ITS) via traditional subcutaneous

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bial Aristegui Italia srl

UNKNOWN

Sponsor Role collaborator

OPBG Contract and Research Organization

UNKNOWN

Sponsor Role collaborator

Mariella Enoc

OTHER

Sponsor Role lead

Responsible Party

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Mariella Enoc

President

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alessandro Fiocchi

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Hospital and Research Institute

Locations

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Operating unit of Allergology

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Fiocchi

Role: CONTACT

Phone: 0039 06.6859.

Email: [email protected]

Chiara Mennini

Role: CONTACT

Phone: 0039 06.6859.

Email: [email protected]

Facility Contacts

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Alessandro Fiocchi

Role: primary

Carmelo Pantaleo

Role: backup

Other Identifiers

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947_OPBG_2014

Identifier Type: -

Identifier Source: org_study_id