ICATA Asthma Mechanistic Study
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ClinicalTrials.gov Identifier: NCT00377390 |
Recruitment Status :
Completed
First Posted : September 18, 2006
Last Update Posted : February 7, 2013
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Condition or disease | Intervention/treatment |
---|---|
Asthma | Biological: Omalizumab |
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.
Study Type : | Observational |
Actual Enrollment : | 224 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Inner-City Anti-IgE Therapy for Asthma Mechanistic Study |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Cockroach sensitive |
Biological: Omalizumab
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). |
Control (cockroach insensitive) |
Biological: Omalizumab
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). |
- 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 [ Time Frame: 1.5 years ]
- Effect of omalizumab therapy on basophil activation markers [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1.5 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 6 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377390
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, Madison | |
Principal Investigator: | 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 |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00377390 |
Other Study ID Numbers: |
DAIT ICAC-09 |
First Posted: | September 18, 2006 Key Record Dates |
Last Update Posted: | February 7, 2013 |
Last Verified: | February 2013 |
Immunoglobulin IgE Omalizumab |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Omalizumab Anti-Allergic Agents Anti-Asthmatic Agents Respiratory System Agents |