ICATA Asthma Mechanistic Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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, 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.

Official Title
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Inner-City Anti-IgE Therapy for Asthma Mechanistic Study

Conditions
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Asthma

Intervention / Treatment
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* Biological: Omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently enrolled in ICATA (ICAC-08, NCT00377572) Clinical Study Positive skin test to German cockroach required for participation in the basophil and T-cell studies and associated procedures Cockroach insensitive participants will serve as control groups

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cockroach sensitive<br> | Biological: Omalizumab<br>* 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).<br>|
| Control (cockroach insensitive)<br> | Biological: Omalizumab<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgE, Immunoglobulin, Omalizumab