Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00079937 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
A Phase 3 study of Asthma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 628
- Enrollment target
- 20
- Study locations
NCT00079937: Completed Phase 3 study of Asthma, sponsored by Novartis Pharmaceuticals.
NCT00079937 is a Phase 3 study of Asthma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 628 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079937, a Phase 3 study of Asthma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 628 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total a
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluticasone
- DRUG Omalizumab
Study Locations (20)
California
- Allergy and Asthma Specialists Medical Group - Huntington Beach
- Pediatric Care and Medical Group - Huntington Beach
- West Coast Clinical Trials - Long Beach
- Southern California Research Center - Mission Viejo
- Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology - Orange
- CA Allergy & Asthma Med Group - Palmdale
- Dr. Joann Blessing-Moore - Palo Alto
- Integrated Research Group - Riverside
- Allergy Associates Medical Group - San Diego
- Allergy and Asthma Medical Group & Research Center - San Diego
- Allergy and Asthma Associates of Santa Clara Valley RC - San Jose
- 1304 15th St - Santa Monica
- Bensch Research Associates - Stockton
- Allergy & Asthma Med Group of Diablo Valley CR - Walnut Creek
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
- Clinical Research Center - Little Rock
Alabama
- Alabama Allergy and Asthma Center - Birmingham
Colorado
- National Jewish Medical and Research Center - Denver
Florida
- Miami Children's Hospital - Miami
Georgia
- Georgia Pollens - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2004-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00079937 record still lists
NCT00079937 is an interventional study that assigns participants to a tested intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00079937 names 20 study sites across 6 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT00079937 about?
NCT00079937 is a clinical study titled "Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma". 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. Th...
What is the current status of trial NCT00079937?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 628 participants. The study started on 2004-04. Estimated completion is 2008-03.
What conditions does trial NCT00079937 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT00079937?
The interventions under investigation include: Placebo (DRUG), Fluticasone (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT00079937?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00079937 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00079937's enrollment target sits among peer trials
628 63rd of 374 higher than 311 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
RECRUITING · Phase 3
-
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
RECRUITING · Phase 3
-
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
RECRUITING · Phase 3
-
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
RECRUITING · Phase 3
-
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04704921 · 630 participants · Phase 2
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
- NCT04707729 · 630 participants · NA
ROX Index for the Timing of Intubation in Nasal High Flow
- NCT05061550 · 630 participants · Phase 2
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
- NCT05224440 · 630 participants · NA
National Sponsorship Program for Transitioning Service Members
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia