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Specific Immunotherapy for Allergic Child

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ClinicalTrials.gov Identifier: NCT02965612
Recruitment Status : Unknown
Verified November 2016 by Mariella Enoc, Bambino Gesù Hospital and Research Institute.
Recruitment status was:  Recruiting
First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborators:
Bial Aristegui Italia srl
OPBG Contract and Research Organization
Information provided by (Responsible Party):
Mariella Enoc, Bambino Gesù Hospital and Research Institute

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Asthma Grass Allergy Device: Injex Procedure: SCIT Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child
Study Start Date : May 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. prevalence of pain [ Time Frame: monthly for 6 month ]
    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 :
  1. prevalence of pain [ Time Frame: 20 minutes after every administration ]
    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.

  2. Incidence of procedure adverse events [ Time Frame: within 24-48 hours after every administration ]
    adverse events related to the different procedure used for the administration of the specific immunotherapy

  3. Incidence of procedure adverse events [ Time Frame: 6 month ]
    adverse event related to the different procedure used for the administration of the specific immunotherapy recorded by the patient on a special diary



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965612


Contacts
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Contact: Alessandro Fiocchi 0039 06.6859. ext 4777-3570 agiovanni.fiocchi@opbg.net
Contact: Chiara Mennini 0039 06.6859. ext 2572 chiara.mennini@opbg.net

Locations
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Italy
Operating unit of Allergology Recruiting
Rome, Italy
Contact: Alessandro Fiocchi    0039 06.6859. ext 4777-3570    agiovanni.fiocchi@opbg.net   
Contact: Carmelo Pantaleo    +39 06 6859 ext 3899    carmelo.pantaleo@opbg.net   
Sponsors and Collaborators
Mariella Enoc
Bial Aristegui Italia srl
OPBG Contract and Research Organization
Investigators
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Principal Investigator: Alessandro Fiocchi Bambino Gesù Hospital and Research Institute

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Responsible Party: Mariella Enoc, President, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02965612     History of Changes
Other Study ID Numbers: 947_OPBG_2014
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mariella Enoc, Bambino Gesù Hospital and Research Institute:
Grass Allergy
Allergic Rhinitis
Allergic Asthma
Paediatric

Additional relevant MeSH terms:
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Immunologic Factors
Rhinitis
Rhinitis, Allergic
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Physiological Effects of Drugs