Allergic Asthma, Allergic Rhinitis, Grass Allergy
Conditions
Keywords
Grass Allergy, Allergic Rhinitis, Allergic Asthma, Paediatric
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).
Interventions
DEVICEInjex
administration of Specific Immunotherapy (ITS) with car pressure injector without a needle
PROCEDURESCIT
administration of Specific Immunotherapy (ITS) via traditional subcutaneous
Sponsors
Bial Aristegui Italia srl
OPBG Contract and Research Organization
Mariella Enoc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of pain | 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
| Measure | Time frame | Description |
|---|---|---|
| prevalence of pain | 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. |
| Incidence of procedure adverse events | within 24-48 hours after every administration | adverse events related to the different procedure used for the administration of the specific immunotherapy |
Countries
Italy
Contacts
Primary ContactAlessandro Fiocchi
Backup ContactChiara Mennini
Outcome results
None listed