Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
224 participants
OBSERVATIONAL
2006-10-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cockroach sensitive
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)
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
6 Years
20 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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William W. Busse, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Jacqueline Pongracic, MD
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Carolyn Kercsmar, MD
Role: PRINCIPAL_INVESTIGATOR
Rainbow Babies and Children's Hospital
Rebecca S. Gruchalla, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Hugh Sampson, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Children's Memorial Hospital
Chicago, Illinois, United States
Mount Sinai School of Medicine
New York, New York, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Courtney AU, McCarter DF, Pollart SM. Childhood asthma: treatment update. Am Fam Physician. 2005 May 15;71(10):1959-68.
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.
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.
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.
Related Links
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Click here for more information on DAIT ICAC-08
Other Identifiers
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DAIT ICAC-09
Identifier Type: -
Identifier Source: org_study_id
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