Status:
COMPLETED
Inner-City Anti-IgE Therapy for Asthma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Inner-City Asthma Consortium
Conditions:
Asthma
Eligibility:
All Genders
6-20 years
Phase:
PHASE4
Brief Summary
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 alon...
Detailed Description
This study is testing a medication called omalizumab for the treatment of asthma. Immunoglobulin E (IgE) is produced when one is exposed to allergens and it can cause inflammation in the lungs. Omaliz...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00377572
Start Date
October 1 2006
End Date
December 1 2009
Last Update
March 21 2017
Active Locations (8)
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1
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 245018
2
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Children's Memorial Hospital
Chicago, Illinois, United States, 60614