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Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)
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.
While the increase in the prevalence of asthma has abated, levels of asthma morbidity and mortality remain near record highs. An asthma exacerbation is a major factor contributing to morbidity, and even mortality in patients with asthma. Although current approaches to treatment have reduced these risks, asthma exacerbations are major problems for inner-city patients and their families, and prevention of these events continues to be a significant challenge. In children with asthma, there are predictable seasonal epidemics of exacerbations, especially during the fall season, otherwise known as the "September epidemic."
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 1, 2011
Primary Completion Date
December 1, 2013
Completion Date
March 1, 2014
Last Updated
May 30, 2017
478
ACTUAL participants
Omalizumab
BIOLOGICAL
Inhaled Corticosteroid Boost Therapy (ICS)
DRUG
Placebo omalizumab
BIOLOGICAL
Placebo fluticasone
BIOLOGICAL
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT02327897
NCT07219173
NCT07486401
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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.
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