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Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

NCT01430403 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2017-05-30

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Omalizumab

Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) \[IU/mL\] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.

DRUG

Inhaled Corticosteroid Boost Therapy (ICS)

Self-administered fluticasone (Flovent ® Diskus®) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone. All participants will receive standardized specialist asthma care.

BIOLOGICAL

Placebo omalizumab

Placebo was administered subcutaneously every 2 or 4 weeks over a period of 4 to 5 months. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP, 2007) guidelines, under the management of an asthma specialist health care provider.

BIOLOGICAL

Placebo fluticasone

Self-administered placebo fluticasone (placebo Flovent ® Diskus®) inhalers identical in dose and guidance as active fluticasone. All participants will receive standardized specialist asthma care.

Sponsors & Collaborators

  • Inner-City Asthma Consortium

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stanley Szefler, MD · National Jewish Health

  • Stephen Teach, MD, MPH · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01430403 on ClinicalTrials.gov