AsthmaNCT00090740
Genetic Risk Factors for Severe Asthma
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Asthma
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Diagnosis of asthma
- No diagnosis of asthma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
The purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms.
Read the 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | People who have asthma | |
| Controls | People who do not have asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of the relationship between the IL-16 promoter genotype and the presence of the asthma phenotype
Measured: Throughout study
Examination of the relationship between the IL-16 promoter genotype and asthma severity
Measured: 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
Measured: Throughout study
Secondary outcomes (1)
Storage of DNA from all 600 participants for future study into the determinants of asthma severity
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2004 (estimated)
- Study startSep 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- George O'Connor, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090740
- Sponsor's protocol ID
- DAIT P01 AI50516
- Status last verified
- Jan 2013
- First submitted
- 3 Sep 2004
- Last updated
- 25 Jan 2013
- Results posted
- No
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. doi: 10.1067/mai.2000.107926.
PubMed 10887316Xu 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. doi: 10.1086/320589. Epub 2001 May 10.
PubMed 11349227Lee 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. doi: 10.1378/chest.122.1.171.
PubMed 12114354Szalai 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. doi: 10.1067/mai.2001.117930.
PubMed 11544456
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk Factors for Severe Asthma
- ClinicalTrials.gov ID
- NCT00090740
- Acronym / sponsor ID
- DAIT P01 AI50516
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 6 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | – | –People who have asthma |
| Controls | – | –People who do not have asthma |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of asthma
- No diagnosis of asthma
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Storage of DNA from all 600 participants for future study into the determinants of asthma severity
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
- Background: PubMed 10887316Sandford 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. doi: 10.1067/mai.2000.107926.
- Background: PubMed 11349227Xu 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. doi: 10.1086/320589. Epub 2001 May 10.
- Background: PubMed 12114354Lee 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. doi: 10.1378/chest.122.1.171.
- Background: PubMed 11544456Szalai 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. doi: 10.1067/mai.2001.117930.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George O'Connor, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination of the relationship between the IL-16 promoter genotype and the presence of the asthma phenotype (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00090740, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.