A Phase 2 interventional study of Omalizumab and Placebo in Asthma in Children, Atopy and Viral Upper Respiratory Infection, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Children's National Research Institute · Phase 2, Interventional, and Treatment
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.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet the following:
At least one of the following criteria:
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Omalizumab
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)
Drug: Placebo
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
Also known as: Xolair
Matching placebo for omalizumab will be provided in 0.5 mL and 1 mL solution for injection in pre-filled syringes.
Also known as: Placebo for omalizumab
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
Time frame: 3-6 day period after injection of study drug/placebo
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
Time frame: 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.
Time frame: 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
Time frame: 3-6 day period after injection of study drug/placebo
Local and systemic immune responses as measured by immune cellular phenotyping
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by immune cellular phenotyping
Time frame: 3-6 day period after injection of study drug/placebo
Local and systemic immune responses as measured by gene expression profiling
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by gene expression profiling
Time frame: 3-6 day period after injection of study drug/placebo
Local and systemic immune responses as measured by proteome
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by proteome
Time frame: 3-6 day period after injection of study drug/placebo
Local and systemic immune responses as measured by metabolome
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by metabolome
Time frame: 3-6 day period after injection of study drug/placebo
Asthma symptoms
To examine the effect of single-dose omalizumab vs placebo on days of asthma symptoms in the prior 14 days
Time frame: 14 day period before sick visit C
Albuterol use
To examine the effect of single-dose omalizumab vs placebo on days of albuterol use in the prior 14 days
Time frame: 14 day period before sick visit C
Asthma Control Test
To examine the effect of single-dose omalizumab vs placebo on values derived from the Asthma Control Test
Time frame: 14-20 days after injection of study drug/placebo
Pediatric Asthma Severity Score
To examine the effect of single-dose omalizumab vs placebo on the Pediatric Asthma Severity Score
Time frame: 3-6 day period after injection of study drug/placebo
Missed full school days
To examine the effect of single-dose omalizumab vs placebo on missed full school days over the prior 14 days
Time frame: 14 day period before sick visit C
Spirometry
To examine the effect of single-dose omalizumab vs placebo on spirometry parameters (FEV1, FVC, FEV1/FVC)
Time frame: 3-6 day period after injection of study drug/placebo
Unscheduled healthcare utilization (asthma-related urgent care visits, emergency department visits, hospitalizations) during the observation period
To examine the effect of single-dose omalizumab vs placebo on the rate of unscheduled healthcare utilization (asthma-related urgent care visits, emergency department visits, hospitalizations) during the post-randomization observation period (from injection to end of each participant's study participation)
Time frame: period from injection of study drug/placebo through study completion, a range of 60-150 days
Total Nasal Symptom Score
To examine the effect of single-dose omalizumab vs placebo on the Total Nasal Symptom Score
Time frame: 14-20 days after injection of study drug/placebo
Modified Rhinitis Symptoms Utility Index
To examine the effect of single-dose omalizumab vs placebo on the Modified Rhinitis Symptoms Utility Index
Time frame: 14 day period before sick visit C
Reliever medication usage (short acting beta agonists and systemic steroids)
To examine the effect of single-dose omalizumab vs placebo on reliever medication usage (short acting beta agonists and systemic steroids) during the post-randomization observation period (from injection to end of each participant's study participation)
Time frame: period from injection of study drug/placebo through study completion, a range of 60-150 days
Plan to share: No
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Jan 2028, 68 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Omalizumab
Children's National Research Institute →