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

August 26, 2009 updated by: Rush University Medical Center

Cytokine Production in Children With Asthma.

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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

Outcome Measure
Time Frame
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)
7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Byung H Yu, MD, Rush University Medical Center, Department of Immunology and Microbiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 26, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L06121901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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