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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00377390 |
The purposes of this study are to determine the effects of omalizumab on cells involved in the allergic response, to evaluate predictors of response to omalizumab, and to determine whether response to omalizumab therapy is influenced by the environment. A subset of inner-city children and adolescents currently enrolled in Inner-City Anti-IgE Therapy for Asthma (a clinical trial of omalizumab) will be enrolled in this study.
Condition |
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Asthma |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Inner-City Anti-IgE Therapy for Asthma Mechanistic Study |
Blood samples, sputum, and nasal secretions
Estimated Enrollment: | 200 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | September 2009 |
Groups/Cohorts |
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Participants who qualify for the ICATA Clinical Study
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Participants who have a positive skin test to German cockroach will be included in the basophil or T-cell studies. Cockroach insensitive participants will serve as control groups.
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Immunoglobulin E (IgE) is important in the development of allergic responses and may determine asthma severity. Omalizumab is a man-made monoclonal antibody that directly blocks the cause of allergic reactions. There are three main objectives to this study. The first is to gain an understanding of how omalizumab affects cells involved in the immune response. The second objective is to determine whether response to omalizumab is influenced by exposure to environmental factors, including allergens and viral infections. The third objective is to determine what clinical markers can be used to determine which patients would most benefit from omalizumab therapy. This study will evaluate the immune and allergic responses of inner-city children with moderate to severe asthma who are receiving omalizumab or placebo as part of a parallel study (Inner-City Anti-IgE Therapy for Asthma).
Nasal secretions will be collected from all participants at the beginning of this study, toward the middle of the study, and with each asthma exacerbation requiring a clinical visit. Some participants will participate in either the basophil or T-cell studies and associated procedures. These studies require blood collection at five study visits. Sputum collection will occur at four study visits. Those participants involved in the basophil studies will also undergo skin testing at three study visits.
Ages Eligible for Study: | 6 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inner-city children and adolescents ages 6 to 20 with asthma who are currently enrolled in the ICATA Clinical Study
Inclusion Criteria:
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Rainbow Babies and Children's Hospital | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Study Chair: | William W. Busse, MD | University of Wisconsin Hospital and Clinics |
Principal Investigator: | Jacqueline Pongracic, MD | Children's Memorial Hospital |
Principal Investigator: | Carolyn Kercsmar, MD | Rainbow Babies and Children's Hospital |
Principal Investigator: | Rebecca S. Gruchalla, MD, PhD | University of Texas Southwestern Medical Center |
Principal Investigator: | Hugh Sampson, MD | Mount Sinai School of Medicine |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT ICAC-09 |
Study First Received: | September 14, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00377390 |
Health Authority: | United States: Food and Drug Administration |
Immunoglobulin IgE Omalizumab |
Antibodies Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Immunoglobulins Omalizumab Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |