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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks after injection of study drug/placebo
Awards & highlights
OBOE Trial 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.Check my eligibility
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.See study design
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.
OBOE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My insurance covers medications that are commonly used for my condition.
Select...
I agree to use approved birth control methods during the study.
Select...
My IgE levels and weight match the requirements for omalizumab treatment.
Select...
I am between 6 and 17 years old.
Select...
I have been diagnosed with persistent asthma by a doctor.
Select...
I am capable of becoming pregnant and have a negative pregnancy test.
OBOE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nasal interferon-α (IFN-α)
Secondary outcome measures
Asthma Exacerbations
Change in type 2 cytokine levels as a function of nasal airway microbiome
Nasal Type 2 Cytokines
Other outcome measures
Albuterol use
Asthma Control Test
Asthma symptoms
+11 moreSide effects data
From 2016 Phase 4 trial • 17 Patients • NCT0202315177%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omalizumab
OBOE 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
Find a Location
Who is running the clinical trial?
Stephen J. Teach, MD, MPHLead Sponsor
3 Previous Clinical Trials
830 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,484,937 Total Patients Enrolled
Stephen Teach, MD, MPHPrincipal InvestigatorChildren's National Research Institute
4 Previous Clinical Trials
1,162 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.You need to provide a nasal absorption sample within 72 hours of having a cold, as determined by the study doctor.You have tested negative for COVID-19 using a rapid nasal swab test.I've needed steroids for asthma at least once in the last 6 months or twice in the last year.I agree to use approved birth control methods during the study.I have had severe asthma attacks requiring breathing help or caused heart or breathing stoppage.My guardian and I agree to follow the study rules and have given our consent.It's been over 14 days since I last needed steroids for an asthma attack.You have another ongoing medical condition.My IgE levels and weight match the requirements for omalizumab treatment.I am between 6 and 17 years old.You live in a city where at least 10% of families have low income and/or use publicly funded health insurance.You are allergic to at least one common airborne allergen that is present year-round.You have high levels of certain blood cells or antibodies that indicate allergies.I have been diagnosed with persistent asthma by a doctor.I am capable of becoming pregnant and have a negative pregnancy test.You have shown symptoms of a cold or flu in the last 3 days, as confirmed by the study doctor.I cannot take omalizumab due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Omalizumab
- Group 2: Placebo for omalizumab
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Omalizumab gained the endorsement of the FDA?
"Omalizumab's safety was rated at a 2 on our team's scale due to the lack of data regarding its efficacy but still existing evidence in regards to its potential risks."
Answered by AI
Is this clinical investigation currently accessible to participants?
"Affirmative. According to clinicaltrials.gov, this medical trial, which was initially posted on May 1st 2022 and last updated on August 26th 2022 is actively seeking out patients for participation. The study requires 300 people from a single location."
Answered by AI
Are seniors being recruited for participation in this investigation?
"Those wishing to join this trial must be between 6 and 17 years of age. 79 trials are available for minors, while 68 are offered to senior citizens."
Answered by AI
How many individuals are currently taking part in this research endeavor?
"Affirmative. The information from clinicaltrials.gov verifies that this trial, which was first posted on May 1st 2022, is actively recruiting participants. Approximately 300 individuals are sought from a single medical centre for the study's completion."
Answered by AI
Is it possible to participate in this research program?
"This clinical trial seeks 300 children aged between 6 and 17 who are suffering from upper respiratory infections. Crucially, each candidate must meet the listed criteria which include: Parental/guardian informed consent in English language, Assent provided by participants over 7 years of age, Sensitisation to at least one perennial aeroallergen, Total serum IgE level appropriate for omalizumab dosing; Insurance that covers standard care medications; Primary family residence (where child sleeps most nights) within Metropolitan Statistical Area with 10% or more families under poverty line and/or publicly funded healthcare coverage; Serum IgE >300k"
Answered by AI
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