Using omalizumab to prevent asthma exacerbations in children

Omalizumab Before Onset of Exacerbations

This study is testing if a single dose of omalizumab can help children aged 6-17 with asthma avoid worsening symptoms during colds and infections.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Children's National Research Institute (Academic / other)
• Drugs / interventions: omalizumab, immunotherapy
• Locations: 1 site (Washington D.C., District of Columbia)
• Trial ID: NCT05332067 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effects of a single dose of omalizumab, an anti-IgE medication, compared to a placebo in children aged 6-17 years with persistent asthma who are prone to exacerbations. Participants will be recruited over three years and will undergo a run-in period to stabilize their asthma control before receiving treatment at the onset of upper respiratory infections. The study aims to measure changes in nasal interferon-alpha levels as a primary outcome, indicating the immune response to treatment. Routine asthma care will be provided throughout the study to ensure optimal management of participants' conditions.

Who should consider this trial

Good fit: Ideal candidates are children aged 6-17 with persistent asthma and a history of exacerbations requiring corticosteroids.

Not a fit: Patients without a history of asthma exacerbations or those not sensitized to perennial aeroallergens may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce asthma exacerbations in at-risk children during viral infections.

How similar studies have performed: Previous studies have shown promise in using omalizumab for asthma management, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria at Study Entry:

Participants must meet the following:

1. Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent
2. 6-17 years, inclusive at time of screening
3. Physician-diagnosed persistent asthma
4. ≥1 exacerbation of asthma requiring systemic corticosteroids in the 6-month period before the planned start of the participant's upcoming school year or ≥2 exacerbations of asthma requiring systemic corticosteroids in the 12-month period before the planned start of the participant's upcoming school year
5. Sensitization to ≥1 perennial aeroallergen
6. Total serum IgE and weight appropriate for omalizumab dosing
7. Insurance that covers standard of care medications
8. Primary family residence (home where child sleeps a majority of nights) in a Metropolitan Statistical Area where ≥10% of families have income below poverty line and/or publicly funded health insurance
9. At least one of the following criteria:

   1. peripheral eosinophilia \>300µL
   2. total serum IgE \>300kU/L
   3. sensitization to ≥3 perennial aeroallergens
10. Females of childbearing potential must have a negative pregnancy test upon study entry
11. Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study

Additional Inclusion Criteria (these must be met prior to randomization at the fall season sick visit A (SVa) during the 90-day outcome period):

In order to be eligible for randomization at the SVa visit, participants must also meet all of the following criteria:

1. Reporting onset of URI symptoms within 72 hours prior to SVa, confirmed by the study physician
2. Report no use of nasal corticosteroids or nasal vaccinations within 14 days prior to SVa
3. Have a negative rapid nasal swab antigen test for SARS-CoV-2
4. Be more than 14 days from the onset of any previous asthma exacerbation requiring systemic steroids
5. Have no current lower respiratory symptoms that, in the opinion of the study physician, require systemic corticosteroid treatment
6. Complete collection of nasal absorption sample within 72 hours of onset URI \[defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms)\] as determined by the study physician's assessment at the SVa visit

Exclusion Criteria:

1. Inability or unwillingness of a participant's parent or guardian to give written informed consent or comply with study protocol or inability or unwillingness of a participant ≥7 to provide assent
2. Contraindication to receipt of omalizumab
3. Presence of a second chronic medical condition (including but not limited to serious cardiorespiratory disorders, cancer, sickle cell disease, uncontrolled seizure disorder, auto-immune disorders, or type 1 diabetes)
4. Pregnancy or active lactation
5. History of latex allergy
6. Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months
7. Plan for home schooling during the 90-day outcome period
8. History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest
9. Inability of primary caregiver and child to speak English
10. In the opinion of the investigator, participant will not be able to wean from nasal steroids or to avoid nasal vaccinations during the 90-day fall outcome period
11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Where this trial is running

Washington D.C., District of Columbia

• Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)

Study contacts

• Principal investigator: William Sheehan, MD — Children's National Research Institute
• Study coordinator: William Sheehan, MD

Conditions Asthma in Children; Atopy; Viral Upper Respiratory Infection