Genetic Risk Factors for Severe Asthma

NCT00090740 | Completed

• 1 other identifier: DAIT P01 AI50516
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Examination of the relationship between the IL-16 promoter genotype and the presence of the asthma phenotype

  Throughout study

• Examination of the relationship between the IL-16 promoter genotype and asthma severity

  Throughout study

• Examination of the serum IL-16 concentration and the serum IL-16:IL-9, IL-16:IL-13, and IL-16: TNF-alpha ratios as possible intermediate phenotypes lining the IL-16 promoter genotype to asthma severity

  Throughout study

Secondary Outcomes (1)

• Storage of DNA from all 600 participants for future study into the determinants of asthma severity

  Throughout study

Study Arms (2)

Asthmatics

People who have asthma

Controls

People who do not have asthma

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

400 asthmatics and 200 non-asthmatic controls will be recruited. The 200 non-asthmatics will be matched for age, gender and ethnicity with the asthmatics in the more severe half of the severity distribution. The participants will be from minority populations (at least 30% African-American and at least 30% Hispanic) and generally of lower socioeconomic status.

You may qualify if:

• Diagnosis of asthma
• No diagnosis of asthma

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

• Sandford AJ, Chagani T, Zhu S, Weir TD, Bai TR, Spinelli JJ, Fitzgerald JM, Behbehani NA, Tan WC, Pare PD. Polymorphisms in the IL4, IL4RA, and FCERIB genes and asthma severity. J Allergy Clin Immunol. 2000 Jul;106(1 Pt 1):135-40. doi: 10.1067/mai.2000.107926.

  PMID: 10887316 BACKGROUND

• Xu J, Meyers DA, Ober C, Blumenthal MN, Mellen B, Barnes KC, King RA, Lester LA, Howard TD, Solway J, Langefeld CD, Beaty TH, Rich SS, Bleecker ER, Cox NJ; Collaborative Study on the Genetics of Asthma. Genomewide screen and identification of gene-gene interactions for asthma-susceptibility loci in three U.S. populations: collaborative study on the genetics of asthma. Am J Hum Genet. 2001 Jun;68(6):1437-46. doi: 10.1086/320589. Epub 2001 May 10.

  PMID: 11349227 BACKGROUND

• Lee SY, Lee YH, Shin C, Shim JJ, Kang KH, Yoo SH, In KH. Association of asthma severity and bronchial hyperresponsiveness with a polymorphism in the cytotoxic T-lymphocyte antigen-4 gene. Chest. 2002 Jul;122(1):171-6. doi: 10.1378/chest.122.1.171.

  PMID: 12114354 BACKGROUND

• Szalai C, Kozma GT, Nagy A, Bojszko A, Krikovszky D, Szabo T, Falus A. Polymorphism in the gene regulatory region of MCP-1 is associated with asthma susceptibility and severity. J Allergy Clin Immunol. 2001 Sep;108(3):375-81. doi: 10.1067/mai.2001.117930.

  PMID: 11544456 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

40 mL blood

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

• George O'Connor, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2004
• First Posted: September 6, 2004
• Study Start: September 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)