Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
Public ClinicalTrials.gov record NCT01430403. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01430403
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Interventions
- Omalizumab Biological
- Inhaled Corticosteroid Boost Therapy (ICS) Drug
- Placebo omalizumab Biological
- Placebo fluticasone Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Nov 30, 2013
- Completion
- Feb 28, 2014
- Last update posted
- May 29, 2017
2011 – 2014
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Memorial Hospital - Department of Allergy | Chicago | Illinois | 60614-3363 | — |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01430403, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 29, 2017 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01430403 live on ClinicalTrials.gov.