An observational study in Food; Allergy, Anaphylactic Shock and Asthma in Children, sponsored by Bambino Gesù Hospital and Research Institute. Completed at 1 site in Italy. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Bambino Gesù Hospital and Research Institute · Observational
A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment.
Children (6-18 yrs) with severe asthma eligible for treatment with Omalizumab and reporting food anaphylaxis to be assessed for their concomitant food allergy.
At T0:
At T1 - four months after starting Omalizumab treatment:
At T2 - eight months after starting Omalizumab treatment:
At T1 - twelve months after starting Omalizumab treatment:
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's enrollment of 65 is below the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Bambino Gesù Hospital and Research Institute is the lead sponsor of 54 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Omalizumab will be administered i.m. with doses ranging from 150 mg every 28 days to 600 mg every 14 days, according to EMA dosing range table.
Biological: Omalizumab
Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.
Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.
Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food
Time frame: Four months (T1)
Proportion of negative OFCs at T1
Percentage of OFC tolerated until the last dose of food.
Time frame: Four months (T1)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.
Change in the NOAEL at the third OFC to the foods who did not pass the OFC at T1
Time frame: Eight months (T2)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.
Change in the NOAEL at the fourth OFC to the foods who did not pass the OFC at T2
Time frame: Twelve months (T3)
Change in number of anaphylactic events
Number of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab
Time frame: Twelve months (T3)
Rate of severity of anaphylactic events
Severity of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab; PRACTALL score: 1 - mild, 2 - moderate, 3 - severe.
Time frame: Twelve months (T3)
Asthma Control Test (ACT)
Change from baseline in ACT score: 5 worse, 25 better outcome
Time frame: Twelve months (T3)
Quality of Life score
Change from baseline in age-appropriate FA-QoL score: 0, better; 84, worse outcome
Time frame: Four (T1), eight (T2), twelve (T3) months
Total IgE
Change from baseline in total IgE
Time frame: Four (T1), eight (T2), twelve (T3) months
Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish
Change from baseline in sIgE;
Time frame: Four (T1), eight (T2), twelve (T3) months
Plan to share: Yes — Anonymized Individual Participating Data will be made available to researchers upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact alexfioc@gmail.com
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Bambino Gesù Hospital and Research Institute