Allergic RhinitisNCT02965612
Specific Immunotherapy for Allergic Child
A study testing Injex and SCIT in people with Allergic Rhinitis and Allergic Asthma, run by Mariella Enoc at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Asthma, Grass Allergy
- What is being tested?
- Injex and SCIT
- Type of treatment
- Vaccines, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Operating unit of Allergology
Rome
Alessandro Fiocchi, 0039 06.6859. ext. 4777-3570, agiovanni.fiocchi@opbg.net
Carmelo Pantaleo, +39 06 6859 ext. 3899, carmelo.pantaleo@opbg.net
About this study
Official title: Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child
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.
Read the 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).
- Conditions
- Allergic Rhinitis, Allergic Asthma, Grass Allergy
- Being tested
- Injex, SCIT
- Keywords
- Grass Allergy, Allergic Rhinitis, Allergic Asthma, Paediatric
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjexDevice
administration of Specific Immunotherapy (ITS) with car pressure injector without a needle
SCITProcedure or surgery
administration of Specific Immunotherapy (ITS) via traditional subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Injex |
| 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. Receives: Procedure: SCIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: monthly for 6 month
Secondary outcomes (3)
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.
Measured: 20 minutes after every administration
Incidence of procedure adverse events
adverse events related to the different procedure used for the administration of the specific immunotherapy
Measured: 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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariella Enoc
- Sponsor type
- University, hospital or other
- Collaborators
- Bial Aristegui Italia srl, OPBG Contract and Research Organization
- Responsible party
- Sponsor-investigator, Mariella Enoc, Bambino Gesù Hospital and Research Institute
- Investigators
- Alessandro Fiocchi, Principal investigator, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965612
- Sponsor's protocol ID
- 947_OPBG_2014
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child
- ClinicalTrials.gov ID
- NCT02965612
- Acronym / sponsor ID
- 947_OPBG_2014
- Conditions
- Allergic Rhinitis, Allergic Asthma, Grass Allergy
- Keywords
- Grass Allergy, Allergic Rhinitis, Allergic Asthma, Paediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mariella EnocUniversity, hospital or other
- Collaborators
- Bial Aristegui Italia srl, OPBG Contract and Research Organization
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITS with Injex | Experimental | Device: InjexFor 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 | Procedure: SCITFor 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Children under age 5 and age> 18 years;
- Autoimmune diseases and immunodeficiencies;
- Neoplasms;
- Severe psychological problems;
- Treatment with β-blockers;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injexadministration of Specific Immunotherapy (ITS) with car pressure injector without a needle | Device | ITS with Injex |
| SCITadministration of Specific Immunotherapy (ITS) via traditional subcutaneous | Procedure or surgery | SCIT: ITS via subcutaneous |
Primary outcome
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.
3 secondary outcomes
prevalence of pain
Time frame: 20 minutes after every administration
Incidence of procedure adverse events
Time frame: within 24-48 hours after every administration
Incidence of procedure adverse events
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Fiocchi principal investigator
Bambino Gesù Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injex and SCIT in people with Allergic Rhinitis and Allergic Asthma, run by Mariella Enoc at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Fiocchi (0039 06.6859. ext. 4777-3570, agiovanni.fiocchi@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of pain (time frame: monthly for 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.