ICATA Asthma Mechanistic Study

NCT00377390 | Completed

• 1 other identifier: DAIT ICAC-09
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 4

Brief 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

Asthma

Keywords

Immunoglobulin; IgE; Omalizumab

Outcome Measures

Primary Outcomes (1)

• 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

  1.5 years

Secondary Outcomes (3)

• Effect of omalizumab therapy on basophil activation markers

  1.5 years

• 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

  1.5 years

• 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

  1.5 years

Study Arms (2)

Cockroach sensitive

Biological: Omalizumab

Control (cockroach insensitive)

Biological: Omalizumab

Interventions

Omalizumab BIOLOGICAL

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).

Cockroach sensitive; Control (cockroach insensitive)

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (4)

• Courtney AU, McCarter DF, Pollart SM. Childhood asthma: treatment update. Am Fam Physician. 2005 May 15;71(10):1959-68.

  PMID: 15926412 BACKGROUND

• 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.

  PMID: 12877240 BACKGROUND

• 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.

  PMID: 15801322 BACKGROUND

• 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.

  PMID: 15753890 BACKGROUND

Related Links

• Click here for more information on DAIT ICAC-08

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, sputum, and nasal secretions

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• William W. Busse, MD

  University of Wisconsin, Madison

  STUDY CHAIR

• 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

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (4)