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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.
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, ICAC-08, NCT00377572).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cockroach sensitive |
| ||
| Control (cockroach insensitive) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Biological | Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit, as a part of ICATA (ICAC-08, NCTNCT00377572). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of changes in basophil receptor occupancy with a reduction in maximum symptom days, inhaled corticosteroid dosage, sputum, and peripheral blood eosinophils, and frequency of exacerbations | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of omalizumab therapy on basophil activation markers | 1.5 years | |
| Effect of omalizumab therapy on the skin test response to allergen and correlation of this change in skin test endpoint titration with maximum symptom days | 1.5 years |
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Inclusion Criteria:
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Inner-city children and adolescents ages 6 to 20 with asthma who are currently enrolled in the ICATA Clinical Study
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| Name | Affiliation | Role |
|---|---|---|
| William W. Busse, MD | University of Wisconsin, Madison | Study Chair |
| Jacqueline Pongracic, MD | Ann & Robert H Lurie Children's Hospital of Chicago | 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 | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States | ||
| Mount Sinai School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15926412 | Background | Courtney AU, McCarter DF, Pollart SM. Childhood asthma: treatment update. Am Fam Physician. 2005 May 15;71(10):1959-68. | |
| 12877240 | Background | Federico MJ, Liu AH. Overcoming childhood asthma disparities of the inner-city poor. Pediatr Clin North Am. 2003 Jun;50(3):655-75, vii. doi: 10.1016/s0031-3955(03)00045-2. |
| Label | URL |
|---|---|
| Click here for more information on DAIT ICAC-08 | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Blood samples, sputum, and nasal secretions
| Effect of omalizumab therapy on the skin test response to allergen and correlation of this change in skin test endpoint titration with inhaled corticosteroid dosage, sputum and peripheral blood eosinophils, and frequency of exacerbations | 1.5 years |
| New York |
| New York |
| 10029 |
| United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| 15801322 | Background | Mvula M, Larzelere M, Kraus M, Moisiewicz K, Morgan C, Pierce S, Post R, Nash T, Moore C. Prevalence of asthma and asthma-like symptoms in inner-city schoolchildren. J Asthma. 2005 Feb;42(1):9-16. doi: 10.1081/jas-200044746. |
| 15753890 | Background | Szefler SJ, Apter A. Advances in pediatric and adult asthma. J Allergy Clin Immunol. 2005 Mar;115(3):470-7. doi: 10.1016/j.jaci.2004.12.1123. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |