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ICATA Asthma Mechanistic Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00377390
First received: September 14, 2006
Last updated: February 6, 2013
Last verified: February 2013
  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 Intervention
Asthma
Biological: Omalizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inner-City Anti-IgE Therapy for Asthma Mechanistic Study

Resource links provided by NLM:


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

Blood samples, sputum, and nasal secretions


Enrollment: 224
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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, 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.

  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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 Mount Sinai School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00377390     History of Changes
Other Study ID Numbers: DAIT ICAC-09
Study First Received: September 14, 2006
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014