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ICATA Asthma Mechanistic Study
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00377390
  Purpose

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
Asthma

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Inner-City Anti-IgE Therapy for Asthma Mechanistic Study

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of omalizumab therapy on basophil activation markers [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood samples, sputum, and nasal secretions


Estimated Enrollment: 200
Study Start Date: October 2006
Estimated Study Completion Date: September 2009
Groups/Cohorts
1
Participants who qualify for the ICATA Clinical Study
2
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inner-city children and adolescents ages 6 to 20 with asthma who are currently enrolled in the ICATA Clinical Study

Criteria

Inclusion Criteria:

  • Currently enrolled in ICATA 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377390

Locations
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
Sponsors and Collaborators
Investigators
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
  More Information

Click here for more information on DAIT ICAC-08  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Immunoglobulin
IgE
Omalizumab

Study placed in the following topic categories:
Antibodies
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Immunoglobulins
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 15, 2009