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Interleukin (IL)-13 as a Marker in Pediatrics Asthma

This study has been completed.
Sponsor:
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00968305
First received: August 19, 2009
Last updated: August 26, 2009
Last verified: August 2009
History of Changes
  Purpose

Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cytokine Production in Children With Asthma.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells [ Time Frame: 7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function measured by percent predicted forced expiratory volume in the first second (FEV1%) [ Time Frame: 7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Venous blood was obtained to measure total serum immunoglobulin E, radioallergosorbent test for environmental aeroallergens, and for peripheral blood mononuclear cells isolation


Enrollment: 19
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children with asthma
African American children with clinically diagnosed stable asthma

Detailed Description:

This study examined the relationship between Interleukin (IL)-13 from phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function (measured as FEV1%), and total serum IgE levels in African American children with clinically diagnosed asthma

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

African-American children, ages 8 to 15 years, with clinically diagnosed asthma which had been stable for at least 4 weeks prior to enrollment in the study.

Criteria

Inclusion Criteria:

  • African-American race, born in the U.S.
  • Age 8-15 years
  • Clinical diagnosis of asthma
  • Subject is able to understand and follow verbal instructions in English

Exclusion Criteria:

  • Asthma exacerbation in the 4 weeks preceding the research visit
  • Oral/IV steroid use in the 4 weeks preceding the research visit
  • Upper or lower respiratory tract infection in the 4 weeks preceding the research visit
  • Antibiotic use in the 4 weeks preceding the research visit
  • Use of a short-acting bronchodilator during the 6 hours prior to spirometry (lung function testing)
  • Use of a long-acting bronchodilator during the 12 hours prior to spirometry (lung function testing)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968305

Locations
United States, Illinois
Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Byung H Yu, MD Rush University Medical Center, Department of Immunology and Microbiology
  More Information

No publications provided

Responsible Party: Byung Ho Yu, MD, Department of Immunology and Microbiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00968305     History of Changes
Other Study ID Numbers: L06121901
Study First Received: August 19, 2009
Last Updated: August 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
African American children with stable asthma
Asthma severity
Interleukin 13 from PHA stimulated PBMC
 Lung function (FEV1%)
Total serum IgE
Pediatrics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013