Inner-City Anti-IgE Therapy for Asthma

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.

Key facts

Study ID

NCT00377572

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

419

Starts

2006-10-01

Expected to finish

2009-12-01

Last updated by the study team

2017-03-21

Who can join

Age: 6 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Both body weight and total serum IgE suitable for omalizumab dosing.
• Diagnosis of asthma made by a physician more than 1 year prior to study entry OR diagnosis of asthma made less than 1 year prior to study entry but have had asthma symptoms for longer than 1 year prior to study entry
• Are receiving long-term asthma control therapy OR have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease
• Positive prick skin test to at least one perennial allergen (e.g., dust mite, cockroach, mold, cat, dog, rat, mouse)
• Live in a preselected zip code are
• Able to perform spirometry measurements
• Willing to sign informed consent or have parent or guardian willing to provide informed consent
• Previously had chicken pox or received varicella (chicken pox) vaccine
• Have some form of health care insurance that covers costs of medications

You may not qualify if…

• If participant meets any of these criteria, they are not eligible at that time but may be reassessed:
• Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2
• Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study entry
• Pregnancy or breastfeeding
• Acute sinusitis or chest infection requiring antibiotics within 1 month of study screening
• Currently participating in another asthma-related clinical trial or have previously participated in an another asthma-related trial within 1 month of study entry
• Does not sleep at least 4 nights per week in one home
• Lives with a foster parent
• Does not have access to a phone
• Plans to move during the study
• Previously treated with anti-IgE therapy within 1 year of study entry
• Currently receiving or received hyposensitization therapy to any allergen in the year prior to study entry
• Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach for more than 6 months in the 3 years prior to study entry
• If participant meets any of these criteria, they are not eligible for the study and may not be reassessed:
• Significant medical illness. More information on this criterion can be found in the protocol.
• Certain medications within 4 weeks of study screening. More information on this criterion can be found in the protocol.
• Known hypersensitivity to any ingredients of omalizumab or related drugs
• Diagnosis of cancer, being investigated for possible cancer, or history of cancer
• Will not allow study physician to manage their asthma
• Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)
• History of severe anaphylactoid or anaphylactic reaction(s)

Where it is running

• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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