Genetic Risk Factors for Severe Asthma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 3, 2004

Last Updated Date

February 24, 2009

Start Date ^†

September 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00090740 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Genetic Risk Factors for Severe Asthma

Official Title ^†

Genetic Risk Factors for Severe Asthma

Brief Summary

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

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Cross-Sectional

Condition ^†

Asthma

Intervention ^†

Study Arms / Comparison Groups

People who have asthma
People who do not have asthma

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

600

Completion Date

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria for Asthmatic Participants:

Diagnosis of asthma

Inclusion Criteria for Non-asthmatic Participants:

No diagnosis of asthma

Gender

Both

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090740

Responsible Party

Associate Director, Clinical Research Program, DAIT/NIAID

Secondary IDs ^††

Study Sponsor ^†

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^††

Investigators ^†

Principal Investigator:

George O'Connor, MD

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.