Asthma in ChildrenPhase 2OBOENCT05332067
Omalizumab Before Onset of Exacerbations
A Phase 2 study testing Omalizumab in people with Asthma in Children and Atopy, run by Children's National Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children, Atopy, Viral Upper Respiratory Infection
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 the 12-month period before the planned start of the participant's upcoming school year
- Sensitization to ≥1 perennial aeroallergen
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- 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 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:
- 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 study physician's assessment at the SVa visit
Who cannot join
- 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
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- 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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
William Sheehan, MD, 202-476-5000, wsheehan@cnmc.org
Alicia Mathis, 202-476-5000 ext. 4698, anewcome@childrensnational.org
About this study
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.
- Conditions
- Asthma in Children, Atopy, Viral Upper Respiratory Infection
- Being tested
- Omalizumab, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
Omalizumab dose for each specific participant is based on that participant's weight and total IgE level. Omalizumab is provided by the manufacturer in two strengths:
- For Injection: 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe
PlaceboDrug
Also called Placebo for omalizumab
Matching placebo for omalizumab will be provided in 0.5 mL and 1 mL solution for injection in pre-filled syringes.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | 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) Receives: Drug: Omalizumab |
| Placebo for omalizumab | Placebo comparator | 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal interferon-α (IFN-α)
The change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later
Measured: 3-6 day period after injection of study drug/placebo
Secondary outcomes (3)
Nasal Type 2 Cytokines
Change in the amount of nasal type 2 cytokines recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later
Measured: 3-6 day period after injection of study drug/placebo
Asthma Exacerbations
Rate of exacerbations of asthma requiring systemic steroids in the two weeks following study drug/placebo injection.
Measured: two weeks after injection of study drug/placebo
Change in type 2 cytokine levels as a function of nasal airway microbiome
Change in type 2 cytokine levels between two time points (when study drug/placebo is injected and 3-6 days later) as a function of nasal airway microbiome phenotypes based on the abundance of Moraxella catarrhalis and Streptococcus pneumoniae and other microbial species recovered by nasal wash
Measured: 3-6 day period after injection of study drug/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 May 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, prospective, parallel-group, double-blinded, randomized clinical trial conducted over three consecutive fall seasons.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Sheehan, Children's National Research Institute
- Investigators
- William Sheehan, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332067
- Sponsor's protocol ID
- CAUSE-CNH-01
- Other IDs
- 1U01AI160090-01
- Acronym
- OBOE
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omalizumab Before Onset of Exacerbations
- ClinicalTrials.gov ID
- NCT05332067
- Acronym / sponsor ID
- OBOE / CAUSE-CNH-01
- Conditions
- Asthma in Children, Atopy, Viral Upper Respiratory Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single site, prospective, parallel-group, double-blinded, randomized clinical trial conducted over three consecutive fall seasons.
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: OmalizumabSingle 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) |
| Placebo for omalizumab | Placebo comparator | Drug: PlaceboSingle 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) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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 the 12-month period before the planned start of the participant's upcoming school year
- Sensitization to ≥1 perennial aeroallergen
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmalizumabAlso: XolairOmalizumab dose for each specific participant is based on that participant's weight and total IgE level. Omalizumab is provided by the manufacturer in two strengths: • For Injection: 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe | Drug | Omalizumab |
| PlaceboAlso: Placebo for omalizumabMatching placebo for omalizumab will be provided in 0.5 mL and 1 mL solution for injection in pre-filled syringes. | Drug | Placebo for omalizumab |
Primary outcome
Nasal interferon-α (IFN-α)
Time frame: 3-6 day period after injection of study drug/placebo
The change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later
3 secondary outcomes
Nasal Type 2 Cytokines
Time frame: 3-6 day period after injection of study drug/placebo
Asthma Exacerbations
Time frame: two weeks after injection of study drug/placebo
Change in type 2 cytokine levels as a function of nasal airway microbiome
Time frame: 3-6 day period after injection of study drug/placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Sheehan, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab in people with Asthma in Children and Atopy, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Sheehan, MD (202-476-5000, wsheehan@cnmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal interferon-α (IFN-α) (time frame: 3-6 day period after injection of study drug/placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.