Clinical trialNCT01430403CompletedPhase 4Interventional

Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment478Asthma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Stanley Szefler, MD
National Jewish Health
Study ChairKOL profile →
clinicaltrials.gov ↗
Stephen Teach, MD, MPH
Children's National Research Institute
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

National Jewish Health
Denver, Colorado, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Children'S Memorial Hospital - Department of Allergy
Chicago, Illinois, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Cincinnati Children'S Hospital
Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Inhaled Corticosteroid Boost TherapyOmalizumab →Placebo fluticasonePlacebo omalizumab

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Sept 2011
Primary completion: 31 Dec 2013
Completion: 31 Mar 2014
Last update posted: 30 May 2017
Registered enrollment: 478
Registry id: NCT01430403

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.