Genetic Risk Factors for Severe Asthma - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00090740

Purpose

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

Condition
Asthma

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Genetic Risk Factors for Severe Asthma

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Examination of the relationship between the IL-16 promoter genotype and the presence of the asthma phenotype [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Examination of the relationship between the IL-16 promoter genotype and asthma severity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Storage of DNA from all 600 participants for future study into the determinants of asthma severity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

40 mL blood

Estimated Enrollment:	600
Study Start Date:	September 2004

Groups/Cohorts
1 People who have asthma
2 People who do not have asthma

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 44 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria for Asthmatic Participants:

Diagnosis of asthma

Inclusion Criteria for Non-asthmatic Participants:

No diagnosis of asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090740

Locations

United States, Massachusetts
Boston University School of Medicine	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Alina Doble 617-414-3221 adoble@lung.bumc.bu.edu
Principal Investigator: George O'Connor, MD
Sub-Investigator: Alan Fine, MD
Sub-Investigator: David Center, MD
Sub-Investigator: William Cruikshank, PhD
Sub-Investigator: Kristin Burkart, MD
Sub-Investigator: Frederic Little, MD

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

George O'Connor, MD

More Information

Publications:

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.

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. 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.

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.

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.

Responsible Party:	DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers:	DAIT P01 AI50516
Study First Received:	September 3, 2004
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00090740
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009