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

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ClinicalTrials.gov Identifier: NCT00968305
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : August 28, 2009
Sponsor:
Information provided by:
Rush University Medical Center

Brief Summary:
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 or disease
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

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cytokine Production in Children With Asthma.
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Children with asthma
African American children with clinically diagnosed stable asthma



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

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


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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009

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