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New treatment option for Asthma in Children
Official title Omalizumab Before Onset of Exacerbations
ClinicalTrials.gov ID: NCT05332067
What this study is testing
What is Omalizumab?
Omalizumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for asthma in children.
Also referred to as Xolair.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- at Study Entry: Participants must meet the following:
- Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent
- 6-17 years, inclusive at time of screening
- Physician-diagnosed persistent asthma
- ≥1 exacerbation of asthma requiring systemic corticosteroids in the 6-month period before the planned start of the participant's upcoming school year...
You likely can't join if
- Inability or unwillingness of a participant's parent or guardian to give written informed consent or comply with study protocol or inability or...
- Contraindication to receipt of omalizumab
- Presence of a second chronic medical condition (including but not limited to serious cardiorespiratory disorders, cancer, sickle cell disease...
- Pregnancy or active lactation
- History of latex allergy
- Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months
See the full eligibility criteria
- at Study Entry: Participants must meet the following:
- Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent
- 6-17 years, inclusive at time of screening
- Physician-diagnosed persistent asthma
- ≥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...
- Sensitization to ≥1 perennial aeroallergen
- Total serum IgE and weight appropriate for omalizumab dosing
- Insurance that covers standard of care medications
- 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
- At least one of the following criteria:
- peripheral eosinophilia \>300µL
- total serum IgE \>300kU/L
- sensitization to ≥3 perennial aeroallergens
- Females of childbearing potential must have a negative pregnancy test upon study entry
- Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study Additional (these must be met prior to randomization at the fall season sick visit A (SVa) during...
- Reporting onset of URI symptoms within 72 hours prior to SVa, confirmed by the study physician
- Report no use of nasal corticosteroids or nasal vaccinations within 14 days prior to SVa
- Have a negative rapid nasal swab antigen test for SARS-CoV-2
- Be more than 14 days from the onset of any previous asthma exacerbation requiring systemic steroids
- Have no current lower respiratory symptoms that, in the opinion of the study physician, require systemic corticosteroid treatment
- 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...
- 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
- Contraindication to receipt of omalizumab
- 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)
- Pregnancy or active lactation
- History of latex allergy
- Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months
- Plan for home schooling during the 90-day outcome period
- History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest
- Inability of primary caregiver and child to speak English
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.