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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014