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Completed Phase 3 Interventional Results available

Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

ClinicalTrials.gov ID: NCT00079937

Public ClinicalTrials.gov record NCT00079937. 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 Sep 3, 2026, 5:14 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

A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Study identification

NCT ID
NCT00079937
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
628 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 11 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
Mar 31, 2004
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008
Last update posted
Apr 10, 2012

2004 – 2008

United States locations

U.S. sites
56
U.S. states
25
U.S. cities
51
Facility City State ZIP Site status
Alabama Allergy and Asthma Center Birmingham Alabama 35209
University of Arkansas for Medical Sciences Little Rock Arkansas 72202
Clinical Research Center Little Rock Arkansas 72205
Allergy and Asthma Specialists Medical Group Huntington Beach California 92647
Pediatric Care and Medical Group Huntington Beach California 92647
West Coast Clinical Trials Long Beach California 90806
Southern California Research Center Mission Viejo California 92691
Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology Orange California 92868
CA Allergy & Asthma Med Group Palmdale California 93551
Dr. Joann Blessing-Moore Palo Alto California 94304
Integrated Research Group Riverside California 92506
Allergy Associates Medical Group San Diego California 92120
Allergy and Asthma Medical Group & Research Center San Diego California 92123
Allergy and Asthma Associates of Santa Clara Valley RC San Jose California 95117
1304 15th St Santa Monica California 90404
Bensch Research Associates Stockton California 95207
Allergy & Asthma Med Group of Diablo Valley CR Walnut Creek California 94598
National Jewish Medical and Research Center Denver Colorado 80206
Miami Children's Hospital Miami Florida 33155
Georgia Pollens Albany Georgia 31707
Family Allergy and Asthma Center, PC Atlanta Georgia 30342
Aeroallergy Research Labs of Savannah, Inc Savannah Georgia 31406
Rush University Medical Center Chicago Illinois 60612
Asthma & Allergy Center Elliott Maryland 21042
Northeast Med Research Associates North Dartmouth Massachusetts 02747
St. Louis University School of Medicine St Louis Missouri 63104
Midwest Allergy & Asthma Clinic Omaha Nebraska 68114
Ocean Allergy & Respiratory Research Center Brick New Jersey 08724
UMDNJ Newark New Jersey 07101
Womes And childrens Hospital of Buffalo Buffalo New York 14222
Asthma & Allergy Associates Ithaca New York 14850
Allergy and Asthma Diagnostic Office Liverpool New York 13088
Island Medical Research (Allergy and Asthma Center) Rockville Centre New York 11570
Duke University Medical Center Durham North Carolina 27710
Allergy & Asthma Center of North carolina High Point North Carolina 27262
Bernstein Clinical Research Center Cincinnati Ohio 45231
Resp Dis of Children and Adolescents Oklahoma City Oklahoma 73112
Clinical Research Institute of Southern Oregon Medford Oregon 97504
501 Howard Av Altoona Pennsylvania 16601
West Penn Allegheny General Health System Pittsburgh Pennsylvania 15212
Asthma and Allergy Associates Upland Pennsylvania 19013
AAPRI Clinical Research Institute Lincoln Rhode Island 02865
Allergy Assoc., The ASthma, Allergy & Sinus Ctr Knoxville Tennessee 37922
Vanderbilt University Nashville Tennessee 37203
Pediatric Allergy/Immunology Associates, PA Dallas Texas 75230
Pediatric Pulmonary Association of North Texas Dallas Texas 75230
North Texas Institute for Clinical Trials Fort Worth Texas 76132
Baylor College of Medicine Houston Texas 77030
7707 Fannin/Ste. 195 Houston Texas 77054
Sylvanna Research San Antonio Texas 78229
Copperview Medical Center South Jordan Utah 84095
Childrens Hospital of the Kings Daughters Norfolk Virginia 23507
Virgina Commonwealth Richmond Virginia 23219
A.S.T.H.M.A., Inc. Seattle Washington 98105
508 W 6th Av Spokane Washington 99204
Medical College of Wisconsin Milwaukee Wisconsin 53226

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 NCT00079937, 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 Apr 10, 2012 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00079937 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →