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ICATA Asthma Mechanistic Study

NCT00377390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 224

Last updated 2013-02-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • William W. Busse, MD · University of Wisconsin, Madison

  • Jacqueline Pongracic, MD · Ann & Robert H Lurie Children's Hospital of Chicago

  • Carolyn Kercsmar, MD · Rainbow Babies and Children's Hospital

  • Rebecca S. Gruchalla, MD, PhD · University of Texas Southwestern Medical Center

  • Hugh Sampson, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
6 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377390 on ClinicalTrials.gov