Omalizumab in Severe Asthmatics With Food Allergy (OSAFA)

March 14, 2024 updated by: Bambino Gesù Hospital and Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00145
        • Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food
Four months (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of negative OFCs at T1
Time Frame: Four months (T1)
Percentage of OFC tolerated until the last dose of food.
Four months (T1)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.
Time Frame: Eight months (T2)
Change in the NOAEL at the third OFC to the foods who did not pass the OFC at T1
Eight months (T2)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.
Time Frame: Twelve months (T3)
Change in the NOAEL at the fourth OFC to the foods who did not pass the OFC at T2
Twelve months (T3)
Change in number of anaphylactic events
Time Frame: Twelve months (T3)
Number of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab
Twelve months (T3)
Rate of severity of anaphylactic events
Time Frame: Twelve months (T3)
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.
Twelve months (T3)
Asthma Control Test (ACT)
Time Frame: Twelve months (T3)
Change from baseline in ACT score: 5 worse, 25 better outcome
Twelve months (T3)
Quality of Life score
Time Frame: Four (T1), eight (T2), twelve (T3) months
Change from baseline in age-appropriate FA-QoL score: 0, better; 84, worse outcome
Four (T1), eight (T2), twelve (T3) months
Total IgE
Time Frame: Four (T1), eight (T2), twelve (T3) months
Change from baseline in total IgE
Four (T1), eight (T2), twelve (T3) months
Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish
Time Frame: Four (T1), eight (T2), twelve (T3) months
Change from baseline in sIgE;
Four (T1), eight (T2), twelve (T3) months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bambino Gesù Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1501/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual Participating Data will be made available to researchers upon reasonable request.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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