Omalizumab in Severe Asthmatics With Food Allergy

Sponsor
Bambino Gesù Hospital and Research Institute
Study ID
NCT06316414
Status
Completed

Conditions

  • Asthma in Children
  • Food; Allergy, Anaphylactic Shock

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2018
Status verified
Mar 2024
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023

Study Design

Enrollment
65 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1. [ Time Frame: Four months (T1) ]

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