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| Name | Class |
|---|---|
| Bial Aristegui Italia srl | UNKNOWN |
| OPBG Contract and Research Organization | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injex | Device | administration of Specific Immunotherapy (ITS) with car pressure injector without a needle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes after every administration |
| Incidence of procedure adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Fiocchi | Contact | 0039 06.6859. | 4777-3570 | agiovanni.fiocchi@opbg.net |
| Chiara Mennini | Contact | 0039 06.6859. | 2572 | chiara.mennini@opbg.net |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Fiocchi | Bambino Gesù Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Operating unit of Allergology | Recruiting | Rome | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 21, 2019 | |
| Reset | Jul 23, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 21, 2019 | Jul 23, 2019 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| SCIT | Procedure | administration of Specific Immunotherapy (ITS) via traditional subcutaneous |
|
adverse events related to the different procedure used for the administration of the specific immunotherapy |
| within 24-48 hours after every administration |
| 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 | 6 month |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |