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Genetic Risk Factors for Severe Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090740
First Posted: September 6, 2004
Last Update Posted: January 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
The purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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 ]
  • Examination of the relationship between the IL-16 promoter genotype and asthma severity [ Time Frame: 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 [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • Storage of DNA from all 600 participants for future study into the determinants of asthma severity [ Time Frame: Throughout study ]

Biospecimen Retention:   Samples With DNA
40 mL blood

Estimated Enrollment: 600
Study Start Date: September 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthmatics
People who have asthma
Controls
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090740


Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: George O'Connor, MD
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00090740     History of Changes
Other Study ID Numbers: DAIT P01 AI50516
First Submitted: September 3, 2004
First Posted: September 6, 2004
Last Update Posted: January 25, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases