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Monoclonal Antibodies

Omalizumab for Childhood Asthma (OBOE Trial)

Phase 2

Recruiting

Led By Stephen Teach, MD, MPH

Research Sponsored by Stephen J. Teach, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Insurance that covers standard of care medications

Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study

Must not have

History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two weeks after injection of study drug/placebo

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma.

Who is the study for?

This trial is for urban youth aged 6-17 with persistent asthma, who have had at least one severe asthma attack in the past six months. They must be sensitive to certain allergens, meet specific IgE levels and eosinophil counts, and not currently need steroids for respiratory symptoms. Participants can't join if they're pregnant or lactating, have a latex allergy, plan to homeschool during the study period, or have been treated with omalizumab recently.

What is being tested?

The OBOE trial tests whether a single dose of Omalizumab (anti-IgE) given at the start of upper respiratory infections can help prevent asthma exacerbations in high-risk children during fall. It's compared against a placebo over three years with participants monitored closely for changes in nasal interferon-alpha after treatment.

What are the potential side effects?

Omalizumab may cause injection site reactions, headaches, fever and potential anaphylaxis which is rare but serious. Side effects vary by individual; some might experience none while others could have more pronounced reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My insurance covers medications that are commonly used for my condition.

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I agree to use approved birth control methods during the study.

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My IgE levels and weight match the requirements for omalizumab treatment.

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I am between 6 and 17 years old.

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I have been diagnosed with persistent asthma by a doctor.

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I am capable of becoming pregnant and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe asthma attacks requiring breathing help or caused heart or breathing stoppage.

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My guardian and I agree to follow the study rules and have given our consent.

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I cannot take omalizumab due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ period from injection of study drug/placebo through study completion, a range of 60-150 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~period from injection of study drug/placebo through study completion, a range of 60-150 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and period from injection of study drug/placebo through study completion, a range of 60-150 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nasal interferon-α (IFN-α)

Secondary study objectives

Asthma Exacerbations

Change in type 2 cytokine levels as a function of nasal airway microbiome

Nasal Type 2 Cytokines

Other study objectives

Albuterol use

Asthma Control Test

Asthma symptoms

+11 more

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151

77%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OmalizumabExperimental Treatment1 Intervention

Single dose of omalizumab at the start of a viral upper respiratory infection as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) during the fall outcome season (defined as the 90-day period beginning on each child's return to school)

Group II: Placebo for omalizumabPlacebo Group1 Intervention

Single dose of placebo for omalizumab at the start of a viral upper respiratory infection as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) during the fall outcome season (defined as the 90-day period beginning on each child's return to school)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omalizumab

FDA approved

0 / 9Eligibility criteria met