Clinical trial NCT00377390: ICATA Asthma Mechanistic Study
Official title: Inner-City Anti-IgE Therapy for Asthma Mechanistic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Immunoglobulin
IgE
Omalizumab
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2006-09-18
Enrollment: 224
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: 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
timeFrame: 1.5 years
Secondary outcomes:
measure: Effect of omalizumab therapy on basophil activation markers
timeFrame: 1.5 years
measure: 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
timeFrame: 1.5 years
measure: 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
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Wisconsin, Madison
name: William W. Busse, MD
role: STUDY_CHAIR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Jacqueline Pongracic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainbow Babies and Children's Hospital
name: Carolyn Kercsmar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Rebecca S. Gruchalla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Hugh Sampson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Courtney AU, McCarter DF, Pollart SM. Childhood asthma: treatment update. Am Fam Physician. 2005 May 15;71(10):1959-68.
citation: 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.
citation: 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.
citation: 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.