Trials Sponsors Conditions Drugs Pricing

Conditions

Asthma in Children Food; Allergy, Anaphylactic Shock

Outcome Measures

Primary Outcomes (1)

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
Four months (T1)

Secondary Outcomes (9)

Proportion of negative OFCs at T1
Four months (T1)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.
Eight months (T2)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.
Twelve months (T3)
Change in number of anaphylactic events
Twelve months (T3)
Rate of severity of anaphylactic events
Twelve months (T3)
+4 more secondary outcomes

Study Arms (1)

Severe asthmatics with history of food anaphylaxis

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

Interventions

OmalizumabBiological

Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.

Severe asthmatics with history of food anaphylaxis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

* Children with severe asthma eligible for treatment with Omalizumab consecutively enrolled at the Bambino Gesu Pediatrica Hospital IRCCS in Rome * ACT \< 20 * Food allergy as described * History of food-induced anaphylaxis * positive OFCs with milk, baked milk, egg, baked egg, wheat, peanut, hazelnut, codfish.

You may qualify if:

Age 6 - 18 years

Sponsors & Collaborators

Bambino Gesù Hospital and Research Institute
Otherlead

Study Sites (1)

Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt

Roma, 00145, Italy

Related Publications (3)

Fiocchi A, Artesani MC, Riccardi C, Mennini M, Pecora V, Fierro V, Calandrelli V, Dahdah L, Valluzzi RL. Impact of Omalizumab on Food Allergy in Patients Treated for Asthma: A Real-Life Study. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1901-1909.e5. doi: 10.1016/j.jaip.2019.01.023. Epub 2019 Feb 20.
PMID: 30797778BACKGROUND
Arasi S, Bitetti C, Lo Scalzo L, Spagnoli A, Fabrizi E, Fiocchi A, Cafarotti A. Omalizumab Dose-Related Efficacy in a Cohort of Children With Severe Food Allergy: OSAFA Observational Study. Allergy. 2026 Apr;81(4):1239-1246. doi: 10.1111/all.70228. Epub 2026 Jan 19.
PMID: 41555682DERIVED

MeSH Terms

Conditions

HypersensitivityAnaphylaxis

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Enrollment

65 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 18, 2024

Study Start

January 1, 2018

Actual (reported)

Omalizumab in Severe Asthmatics With Food Allergy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Severe asthmatics with history of food anaphylaxis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Severe asthmatics with history of food anaphylaxis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations