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

NCT00968305 | Completed

• 1 other identifier: L06121901
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

African American children with stable asthma; Asthma severity; Interleukin 13 from PHA stimulated PBMC; Lung function (FEV1%); Total serum IgE; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (1)

Children with asthma

African American children with clinically diagnosed stable asthma

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology

Chicago, Illinois, 60612, United States

Location

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Byung H Yu, MD

  Rush University Medical Center, Department of Immunology and Microbiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 28, 2009
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

US (1)