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Completed

NCT Number: NCT00090740

Genetic Risk Factors for Severe Asthma

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

Completed

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Key information

Conditions

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

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Asthmatic Participants:

  • Diagnosis of asthma

Inclusion criteria

for Non-asthmatic Participants:

  • No diagnosis of asthma

Treatment and study plan

Primary outcomes

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

    Time frame: Throughout study

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

    Time frame: Throughout study

  3. 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

Secondary outcomes

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

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 6, 2004
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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