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Preventing Asthma in High Risk Kids | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Preventing Asthma in High Risk Kids

Controlling and Preventing Asthma Progression and Severity in Kids

NCT02570984•Boston Children's Hospital

Summary

This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.

Detailed Description

Prevention/ Disease modification of asthma.

Eligibility

Age

2 - 3 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff.
•2. 24-47 months of age at randomization
•3. 2-4 wheezing episodes in the past year
•4. positive allergy to aeroallergen
•5. first degree relative with history or current diagnosis of asthma or allergy
•6. If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months.

Exclusion Criteria

•1. \>4 episodes of wheezing in the past year
•2. Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
•3. Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening.
•4. Three or more courses of systemic corticosteroids for wheezing illnesses in the last year
•5. More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity
•6. More than four days of albuterol treatment (for symptoms) in the past two weeks
•7. More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks
•8. More than one night of albuterol treatment (for symptoms) in the past two weeks
•9. Prematurity (\<34 weeks gestation)
•10. Need for oxygen for more than 5 days in the neonatal period
+12 more criteria

Locations (13)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Connecticut Children's Hospital

Hartford, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Indiana University/Riley Children's Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Key Dates

Start Date

November 27, 2018

Primary Completion Date

January 31, 2028

Completion Date

March 31, 2028

Last Updated

December 4, 2025

Enrollment

200

ESTIMATED participants

Conditions

Asthma

Interventions

Omalizumab

DRUG

Placebo

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Preventing Asthma in High Risk Kids

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma