Inner-City Anti-IgE Therapy for Asthma

Summary

The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.

Conditions

• Asthma

Interventions

BIOLOGICAL

omalizumab

Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.

BIOLOGICAL

omalizumab placebo

Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.

Sponsors & Collaborators

• Inner-City Asthma Consortium

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

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

• George T. O'Connor, MD, MS · Boston University

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

• Jamen Chmiel, MD · Rainbow Babies and Children's Hospital

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

• Andrew Liu, MD · National Jewish Health

• Meyer Kattan, MD, CM · Columbia University

• Wayne Morgan, MD, CM · University of Arizona Health Sciences Center

• Stephen Teach, MD, MPH · Children's National Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

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