Genetic Risk Factors for Severe Asthma

Asthma Clinical Trial

Official title:

Genetic Risk Factors for Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090740
• Other study ID #: DAIT P01 AI50516
• Status: Completed
• Phase: N/A
• First received: September 3, 2004
• Last updated: January 23, 2013
• Start date: September 2004
• Est. completion date: January 2005

Study information

• Verified date: January 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

Description:

Asthma is one of the most common chronic diseases in the United States. It is well known that asthma susceptibility is inherited; however, it is unknown if asthma severity is heritable. Studies suggest that levels of interleukin-16 (IL-16) may influence asthma severity. This study will examine the role of differences in the control region of the IL-16 gene in a racially diverse group of asthmatics and nonasthmatics and will determine if the IL-16 gene control region is related to asthma severity.

Participants in this study will undergo lung function and blood tests; they will also complete a questionnaire about their respiratory health. Asthmatic participants will complete a severity-of-asthma questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria for Asthmatic Participants:

• Diagnosis of asthma

Inclusion Criteria for Non-asthmatic Participants:

• No diagnosis of asthma

Study Design

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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

Szalai C, Kozma GT, Nagy A, Bojszkó A, Krikovszky D, Szabó 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. — View Citation

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. Epub 2001 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the relationship between the IL-16 promoter genotype and the presence of the asthma phenotype		Throughout study	No
Primary	Examination of the relationship between the IL-16 promoter genotype and asthma severity		Throughout study	No
Primary	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	No
Secondary	Storage of DNA from all 600 participants for future study into the determinants of asthma severity		Throughout study	No