Is NCT05332067 recruiting in Washington Dc, DC?

Yes, NCT05332067 is currently recruiting participants at its Washington Dc, DC location. This asthma in children clinical trial is actively enrolling qualified participants.

How do I join the asthma in children clinical trial in Washington Dc?

To join this clinical trial in Washington Dc, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Washington Dc clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Asthma in Children Clinical Trial in Washington Dc, DC

About This Asthma in Children Study in Washington Dc

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.

Sponsor: Children's National Research Institute

Who Can Participate

Inclusion 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 the 12-month period before the planned start of the participant's upcoming school year

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 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

Exclusion Criteria

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 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Washington Dc?

Yes, this clinical trial (NCT05332067) has an active research site in Washington Dc, DC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Asthma in Children Treatment Options in Washington Dc, DC

If you're searching for asthma in children treatment options in Washington Dc, DC, this clinical trial (NCT05332067) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Washington Dc research site is actively enrolling participants for this clinical trial. You'll receive care from experienced asthma in children specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all asthma in children clinical trials near you to find additional studies recruiting in your area.

Asthma in Children Clinical Trial in Washington Dc, DC

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