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Food; Allergy, Anaphylactic ShockOSAFANCT06316414

Omalizumab in Severe Asthmatics With Food Allergy

An observational study of Food; Allergy, Anaphylactic Shock and Asthma in Children, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 18 years
What is being tested?
Omalizumab
How many people
65 participants
Where
1 siteItaly
Study dates
1 Jan 2018to 31 Mar 2023
Phase
Observational
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 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • Age 6 - 18 years
  • Severe persistent allergic asthma according to the GINA guidelines
  • Sensitized to a perennial aeroallergen, as witnessed by positive skin test and/or in vitro reactivity
  • Symptoms inadequately controlled with inhaled corticosteroids + another medication, as witnessed by an ACT ≤ 19
  • On treatment with high dose inhaled corticosteroids + another medication. Threshold dose for inhaled corticosteroids set at 400 mcg/day budesonide (or equivalent doses) for children < 12 years, at 800 mcg/day for older patients.
  • Immediate food allergy with anaphylactic symptoms within 1hr. of ingestion of milk, egg, wheat, peanut, hazelnut, and/or codfish.
Show all 13Show fewer
  • Total IgE < 70 and >1,500 kU/L at baseline
  • Sensitivity to food allergen documented by a positive skin prick test result and/or allergen-specific IgE level, with 0.35 kU/L as a lower limit of eligibility
  • Positive OFC within the past 12 months, with minimal or no reactions to the placebo challenge.
  • Trained on the proper use of epinephrine
  • In case of female subjects of child-bearing potential, negative human chorionic gonadotropin blood sample for pregnancy testing
  • No known contraindications to oral immunotherapy with food protein or Omalizumab
  • Parent/legal guardian written informed consent

Who cannot join

  • Total IgE at screening > 70 or ≤ 2,500 kUI/L
  • allergy to food(s) not investigated in this study
  • Immune deficiency
  • Previous reaction to Omalizumab
  • Previous organ transplantation
  • Use of monoclonal antibodies in the previous 6 months
Show all 14Show fewer
  • Subjects with gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease.
  • Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study
  • Pregnant or breast-feeding females.
  • Subjects with food protein induced enterocolitis syndrome (FPIES)
  • Subjects is on a build-up phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose)
  • Inability to discontinue antihistamines for 5 half-lives prior to routine study tests (OFC)
  • Subjects with weight-IgE combination yielding a dose requirement greater than 600 mg according to the EMA schedule for Omalizumab
  • Systemic steroids oral, IM, or IV for indications other than asthma for more than 3 weeks in the past 6 months.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt

    Roma, 00145

Other trials in Italy

About this study

Official title: Effects of Omalizumab on Food Allergy in Children With Severe Asthma: A Real Life Study

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.

Read the detailed description

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:

  • oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s);
  • number and severity of food-allergic reactions in the previous 12 months recorded
  • Asthma Control Test
  • Food Allergy-Quality of Life (FA-QoL) questionnaire
  • total IgE
  • specific IgE for the culprit foods

At T1 - four months after starting Omalizumab treatment:

  • OFCs to the previously positive foods with evaluation of the threshold of reaction
  • number and severity of food-allergic reactions in the previous 4 months recorded
  • Asthma Control Test
  • Food Allergy-Quality of Life (FA-QoL) questionnaire
  • total IgE
  • specific IgE for the culprit foods

At T2 - eight months after starting Omalizumab treatment:

  • OFCs to the previously positive foods with evaluation of the threshold of reaction
  • number and severity of food-allergic reactions in the previous 4 months recorded
  • Asthma Control Test
  • Food Allergy-Quality of Life (FA-QoL) questionnaire
  • total IgE
  • specific IgE for the culprit foods

At T1 - twelve months after starting Omalizumab treatment:

  • OFCs to the previously positive foods with evaluation of the threshold of reaction
  • number and severity of food-allergic reactions in the previous 4 months recorded
  • Asthma Control Test
  • Food Allergy-Quality of Life (FA-QoL) questionnaire
  • total IgE
  • specific IgE for the culprit foods
Being tested
Omalizumab
Medical subject headings
Hypersensitivity, Anaphylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabBiological

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

Study groups in NCT06316414
Study groupRoleWhat they receive
Severe asthmatics with history of food anaphylaxisOmalizumab 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.
Receives: Biological: Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Four months (T1)

Secondary outcomes (9)

  1. Proportion of negative OFCs at T1

    Percentage of OFC tolerated until the last dose of food.

    Measured: Four months (T1)

  2. 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

    Measured: Eight months (T2)

  3. 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

    Measured: Twelve months (T3)

  4. 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

    Measured: Twelve months (T3)

  5. 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.

    Measured: Twelve months (T3)

  6. Asthma Control Test (ACT)

    Change from baseline in ACT score: 5 worse, 25 better outcome

    Measured: Twelve months (T3)

  7. Quality of Life score

    Change from baseline in age-appropriate FA-QoL score: 0, better; 84, worse outcome

    Measured: Four (T1), eight (T2), twelve (T3) months

  8. Total IgE

    Change from baseline in total IgE

    Measured: Four (T1), eight (T2), twelve (T3) months

  9. Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish

    Change from baseline in sIgE;

    Measured: Four (T1), eight (T2), twelve (T3) months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start1 Jan 2018
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316414
Sponsor's protocol ID
1501/17
Acronym
OSAFA
Status last verified
Mar 2024
First submitted
6 Mar 2024
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
Yes: Anonymized Individual Participating Data will be made available to researchers upon reasonable request.

Publications

  • 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.

    PubMed 30797778

  • 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.

    PubMed 41555682

  • Arasi S, Cafarotti A, Galletta F, Panetta V, Riccardi C, Calandrelli V, Fierro V, Dahdah L, Artesani MC, Valluzzi RL, Pecora V, Tallarico V, Dinardo G, Lo Scalzo L, Fiocchi A. Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study. Allergy. 2025 Apr;80(4):1074-1085. doi: 10.1111/all.16314. Epub 2024 Sep 16.

    PubMed 39282750

Questions about this trial

What is this clinical trial studying?

An observational study of Food; Allergy, Anaphylactic Shock and Asthma in Children, run by Bambino Gesù Hospital and Research Institute 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 13 inclusion and 14 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: finished, as of the sponsor's last update on 18 Mar 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316414, which also lists 3 linked publications.

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 18 Mar 2024.

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