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

Asthma Clinical Trial

Official title:

Cytokine Production in Children With Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968305
• Other study ID #: L06121901
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: August 26, 2009
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells		7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject)	No
Secondary	Lung function measured by percent predicted forced expiratory volume in the first second (FEV1%)		7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject)	No