ClinicalTrials.gov record
Completed Phase 4 Interventional Results available

Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

ClinicalTrials.gov ID: NCT01430403

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.

ClinicalTrials.gov public records Last synced May 13, 2026, 9:57 AM EDT

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)

Study identification

NCT ID
NCT01430403
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
478 participants

Conditions and interventions

Conditions

Interventions

  • Inhaled Corticosteroid Boost Therapy (ICS) Drug
  • Omalizumab Biological
  • Placebo fluticasone Biological
  • Placebo omalizumab Biological

Drug · Biological

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 May 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01430403 live on ClinicalTrials.gov.

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