300 Participants Needed

Omalizumab for Childhood Asthma

(OBOE Trial)

ST
AM
Overseen ByAlicia Mathis
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does mention that you should not use nasal corticosteroids or nasal vaccinations within 14 days before a specific visit. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Omalizumab for childhood asthma?

Research shows that Omalizumab can help children with moderate-to-severe asthma by reducing the need for oral corticosteroids (a type of medication that reduces inflammation) and improving lung function. It has been found to be safe and effective in managing asthma symptoms over the long term.12345

Is omalizumab safe for children with asthma?

Omalizumab is generally considered safe for children with moderate-to-severe asthma, with most adverse events being mild to moderate. Studies show that it does not increase the frequency of serious adverse events compared to a placebo.678910

How is the drug omalizumab different from other asthma treatments?

Omalizumab is unique because it is a monoclonal antibody that targets and reduces IgE (a protein involved in allergic reactions), helping to control severe allergic asthma in children who do not respond well to standard treatments like inhaled steroids. It can also reduce the need for oral corticosteroids and decrease asthma attacks and hospital visits.211121314

What is the purpose of this trial?

OBOE is a prospective, pilot, parallel group RCT with the overall aim of 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. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.

Research Team

ST

Stephen Teach, MD. MPH.

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I haven't used nasal sprays or had nasal vaccines in the last 2 weeks.
I don't need steroids for any lung problems right now.
My insurance covers medications that are commonly used for my condition.
See 14 more

Exclusion Criteria

You have had an allergic reaction to latex in the past.
I haven't had omalizumab, other monoclonal antibody, or allergy shots in the last 6 months.
Plan for home schooling during the 90-day outcome period
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants are followed for a 2-6 month run-in period to gain control of asthma and stabilize medication levels

8-24 weeks
2-4 visits (in-person)

Treatment

Single dose of omalizumab or placebo administered at the onset of a viral upper respiratory infection

3-6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including unscheduled healthcare utilization and asthma control

60-150 days

Treatment Details

Interventions

  • Omalizumab
  • Placebo
Trial Overview 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.
Participant Groups
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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stephen J. Teach, MD, MPH

Lead Sponsor

Trials
4
Recruited
1,100+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Findings from Research

In a study of 18 non-atopic asthmatics over 20 weeks, omalizumab therapy significantly reduced bronchial mucosal IgE+ cells, indicating a reduction in inflammation associated with asthma.
Patients receiving omalizumab maintained or improved their lung function after a staged withdrawal of their regular asthma therapy, while those on placebo experienced a decline in lung function.
Omalizumab reduces bronchial mucosal IgE and improves lung function in non-atopic asthma.Pillai, P., Chan, YC., Wu, SY., et al.[2022]
In a 16-week trial involving 34 children with severe asthma, omalizumab significantly reduced the median daily dose of oral prednisolone from 20 mg to 5 mg, with some children completely stopping prednisolone.
Improvements in asthma control and quality of life were observed, as indicated by significant increases in the mini-Asthma Quality of Life Questionnaire and Childhood Asthma Control Test scores, demonstrating the potential of omalizumab as a corticosteroid-sparing treatment.
The oral corticosteroid-sparing effect of omalizumab in children with severe asthma.Brodlie, M., McKean, MC., Moss, S., et al.[2022]
A 52-week study involving 309 children with moderate-to-severe allergic asthma showed that long-term treatment with omalizumab is safe, with adverse events similar to those seen in the placebo group.
The most common side effects were upper respiratory infections and headaches, with no serious adverse events or anaphylactic reactions reported, indicating that omalizumab is well tolerated in this population.
Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma.Berger, W., Gupta, N., McAlary, M., et al.[2015]

References

Omalizumab reduces bronchial mucosal IgE and improves lung function in non-atopic asthma. [2022]
The oral corticosteroid-sparing effect of omalizumab in children with severe asthma. [2022]
Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma. [2015]
Efficacy and safety of omalizumab in children with moderate-to-severe asthma: a meta-analysis. [2021]
Modeling the effects of omalizumab over 5 years among patients with moderate-to-severe persistent allergic asthma. [2019]
Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. [2022]
Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents. [2022]
Efficacy and safety of omalizumab in children and adolescents with moderate-to-severe asthma: A systematic literature review. [2022]
Effectiveness and Safety Studies of Omalizumab in Children and Adolescents With Moderate-To-Severe Asthma. [2023]
[Efficacy and safety of omalizumab in patients with refractory allergic asthma: a meta-analysis]. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Current status of therapy with omalizumab in children. [2015]
Quality of life in asthmatic children and their caregivers after two-year treatment with omalizumab, a real-life study. [2022]
Effectiveness of omalizumab in children and adolescents with uncontrolled allergic asthma: a case series from Poland. [2022]
Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security