ICATA Asthma Mechanistic Study

• ClinicalTrials.gov Identifier: NCT00377390
• Recruitment Status: Completed
• First Posted: September 18, 2006
• Last Update Posted: February 7, 2013
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

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.

Condition or disease	Intervention/treatment
Asthma	Biological: Omalizumab

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 224 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Inner-City Anti-IgE Therapy for Asthma Mechanistic Study
• Study Start Date: October 2006
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Groups and Cohorts

Group/Cohort	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 1.5 years ]

Secondary Outcome Measures :

1. Effect of omalizumab therapy on basophil activation markers [ Time Frame: 1.5 years ]
2. 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 ]
3. 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 ]

Biospecimen Retention:   Samples With DNA

Blood samples, sputum, and nasal secretions

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 20 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: William W. Busse, MD; University of Wisconsin, Madison
• 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; Icahn School of Medicine at Mount Sinai

More Information

Additional Information:

Click here for more information on DAIT ICAC-08 

Publications:

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

Federico MJ, Liu AH. Overcoming childhood asthma disparities of the inner-city poor. Pediatr Clin North Am. 2003 Jun;50(3):655-75, vii. Review.

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.

Szefler SJ, Apter A. Advances in pediatric and adult asthma. J Allergy Clin Immunol. 2005 Mar;115(3):470-7. Review.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00377390
• Other Study ID Numbers: DAIT ICAC-09
• First Posted: September 18, 2006
• Last Update Posted: February 7, 2013
• Last Verified: February 2013

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

Immunoglobulin; IgE; Omalizumab

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Omalizumab; Anti-Allergic Agents; Anti-Asthmatic Agents; Respiratory System Agents