AsthmaNCT00005359
Genetics of Asthma and Bronchial Hyperresponsiveness
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the genetics of asthma by reexamining a carefully characterized population of patients with asthma, and by studying their families. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1994to May 2008
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the genetics of asthma by reexamining a carefully characterized population of patients with asthma, and by studying their families.
Read the detailed description
BACKGROUND:
The development of asthma requires exposure to inciting agents such as allergens and environmental pollutants, as well as the presence of host or genetic factors. Understanding the genetics of bronchial hyperresponsiveness (BHR) and allergy will delineate mechanisms that are important in the pathogenesis and therapy of asthma. While both genetic and environmental factors and their interactions are felt to be important, their precise role is not fully understood.
DESIGN NARRATIVE:
The probands are from the 'asthma' center Beatrixoord in Haren, The Netherlands which was started in 1962. In collaboration with Dr Dirkje Postma of Holland, data are available on approximately 1200 patients who were first studied in 1963-1970 using the same protocol. Family studies of the children and grandchildren of these original probands are underway. At this time, 85 complete families have been characterized and clinical data and DNA are available for analysis in Baltimore. Families are being ascertained so that the investigators can test the fit of genetic models through segregation analyses. The major aim of the study is to identify major genes for bronchial hyperresponsiveness (BHR) and asthma by linkage with highly polymorphic DNA markers. Since allergy is commonly associated with asthma, a second goal of the study is to identify major genes for atopy using similar linkage studies. Allergic factors under study include skin test reactivity to common allergens, serum total and specific IgE levels, and blood eosinophilia. Complex segregation analysis will be performed separately for asthma, BHR and allergy. The most parsimonious model from the segregation analysis will be used for linkage analysis. Initially, candidate regions of the genome will be evaluated. Then, a systematic search of the genome will be performed using highly polymorphic informative makers. When a linkage is detected, candidate genes in that specific area will be studied.
The study was renewed in FY 1999 and in FY 2004 to: further characterize asthma and closely related phenotypes; perform genetic modeling (complex segregation analysis) using one and two locus models as well as bivariate segregation analysis; complete the genome wide screen; fine map regions of interest and identify candidate genes, perform linkage disequilibrium and haplotype sharing analyses; and perform case control analysis of susceptibility and severity candidate genes for asthma.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1994
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)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 Heart, Lung, and Blood Institute (NHLBI)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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Deborah Meyers, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005359
- Sponsor's protocol ID
- 4246
- Other IDs
- R01HL048341-14
- Status last verified
- Jul 2008
- First submitted
- 25 May 2000
- Last updated
- 12 Jul 2016
- Results posted
- No
Publications
Bleecker ER, Postma DS, Meyers DA. Genetic susceptibility to asthma in a changing environment. Ciba Found Symp. 1997;206:90-9; discussion 99-105, 106-10. doi: 10.1002/9780470515334.ch6.
PubMed 9257007Levitt RC, Holroyd KJ. Fine-structure mapping of genes providing susceptibility to asthma on chromosome 5q31-q33. Clin Exp Allergy. 1995 Nov;25 Suppl 2:119-23. doi: 10.1111/j.1365-2222.1995.tb00439.x. No abstract available.
PubMed 8590330Postma DS, Bleecker ER, Amelung PJ, Holroyd KJ, Xu J, Panhuysen CI, Meyers DA, Levitt RC. Genetic susceptibility to asthma--bronchial hyperresponsiveness coinherited with a major gene for atopy. N Engl J Med. 1995 Oct 5;333(14):894-900. doi: 10.1056/NEJM199510053331402.
PubMed 7666875DiSilvestre D, Kleeberger SR, Johns J, Levitt RC. Structure and DNA sequence of the mouse MnSOD gene. Mamm Genome. 1995 Apr;6(4):281-4. doi: 10.1007/BF00352417.
PubMed 7613035Monitto CL, Levitt RC, DiSilvestre D, Holroyd KJ. Localization of the A3 adenosine receptor gene (ADORA3) to human chromosome 1p. Genomics. 1995 Apr 10;26(3):637-8. doi: 10.1016/0888-7543(95)80194-q. No abstract available.
PubMed 7607699Meyers DA, Bleecker ER. Approaches to mapping genes for allergy and asthma. Am J Respir Crit Care Med. 1995 Jul;152(1):411-3. doi: 10.1164/ajrccm.152.1.7599858. No abstract available.
PubMed 7599858Levitt RC, Ewart SL. Genetic susceptibility to atracurium-induced bronchoconstriction. Am J Respir Crit Care Med. 1995 May;151(5):1537-42. doi: 10.1164/ajrccm.151.5.7735612.
PubMed 7735612Levitt RC, Kiser MB, Dragwa C, Jedlicka AE, Xu J, Meyers DA, Hudson JR. Fluorescence-based resource for semiautomated genomic analyses using microsatellite markers. Genomics. 1994 Nov 15;24(2):361-5. doi: 10.1006/geno.1994.1628.
PubMed 7698760Schwengel DA, Jedlicka AE, Nanthakumar EJ, Weber JL, Levitt RC. Comparison of fluorescence-based semi-automated genotyping of multiple microsatellite loci with autoradiographic techniques. Genomics. 1994 Jul 1;22(1):46-54. doi: 10.1006/geno.1994.1344.
PubMed 7959791He P, Ma Y, Zhao G, Dai H, Li H, Chang L, Zhang Z. FaRE1: a transcriptionally active Ty1-copia retrotransposon in strawberry. J Plant Res. 2010 Sep;123(5):707-14. doi: 10.1007/s10265-009-0290-0. Epub 2009 Dec 18.
PubMed 20020171Howard TD, Bleecker ER, Stine OC. Fluorescent allele-specific PCR (FAS-PCR) improves the reliability of single nucleotide polymorphism screening. Biotechniques. 1999 Mar;26(3):380-1. doi: 10.2144/99263bm01. No abstract available.
PubMed 10090967Stine OC, Xu J, Meyers DA, Bleecker ER. Approaches to fine mapping in asthma. Clin Exp Allergy. 1998 Apr;28 Suppl 1:98-100; discussion 108-10. doi: 10.1046/j.1365-2222.1998.0280s1098.x. No abstract available.
PubMed 9641604Panhuysen CI, Bleecker ER, Koeter GH, Meyers DA, Postma DS. Characterization of obstructive airway disease in family members of probands with asthma. An algorithm for the diagnosis of asthma. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1734-42. doi: 10.1164/ajrccm.157.6.9606088.
PubMed 9620899Bleecker ER, Postma DS, Meyers DA. Evidence for multiple genetic susceptibility loci for asthma. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 2):S113-6. doi: 10.1164/ajrccm.156.4.12tac7.
PubMed 9351590Bleecker ER, Amelung PJ, Levitt RC, Postma DS, Meyers DA. Evidence for linkage of total serum IgE and bronchial hyperresponsiveness to chromosome 5q: a major regulatory locus important in asthma. Clin Exp Allergy. 1995 Nov;25 Suppl 2:84-8; discussion 95-6. doi: 10.1111/j.1365-2222.1995.tb00430.x. No abstract available.
PubMed 8590353
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Asthma and Bronchial Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT00005359
- Acronym / sponsor ID
- 4246
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1994
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 May 2000 (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.
To investigate the genetics of asthma by reexamining a carefully characterized population of patients with asthma, and by studying their families.
Detailed description
BACKGROUND:
The development of asthma requires exposure to inciting agents such as allergens and environmental pollutants, as well as the presence of host or genetic factors. Understanding the genetics of bronchial hyperresponsiveness (BHR) and allergy will delineate mechanisms that are important in the pathogenesis and therapy of asthma. While both genetic and environmental factors and their interactions are felt to be important, their precise role is not fully understood.
DESIGN NARRATIVE:
The probands are from the 'asthma' center Beatrixoord in Haren, The Netherlands which was started in 1962. In collaboration with Dr Dirkje Postma of Holland, data are available on approximately 1200 patients who were first studied in 1963-1970 using the same protocol. Family studies of the children and grandchildren of these original probands are underway. At this time, 85 complete families have been characterized and clinical data and DNA are available for analysis in Baltimore. Families are being ascertained so that the investigators can test the fit of genetic models through segregation analyses. The major aim of the study is to identify major genes for bronchial hyperresponsiveness (BHR) and asthma by linkage with highly polymorphic DNA markers. Since allergy is commonly associated with asthma, a second goal of the study is to identify major genes for atopy using similar linkage studies. Allergic factors under study include skin test reactivity to common allergens, serum total and specific IgE levels, and blood eosinophilia. Complex segregation analysis will be performed separately for asthma, BHR and allergy. The most parsimonious model from the segregation analysis will be used for linkage analysis. Initially, candidate regions of the genome will be evaluated. Then, a systematic search of the genome will be performed using highly polymorphic informative makers. When a linkage is detected, candidate genes in that specific area will be studied.
The study was renewed in FY 1999 and in FY 2004 to: further characterize asthma and closely related phenotypes; perform genetic modeling (complex segregation analysis) using one and two locus models as well as bivariate segregation analysis; complete the genome wide screen; fine map regions of interest and identify candidate genes, perform linkage disequilibrium and haplotype sharing analyses; and perform case control analysis of susceptibility and severity candidate genes for asthma.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 12 Jul 2016.
- Background: PubMed 9257007Bleecker ER, Postma DS, Meyers DA. Genetic susceptibility to asthma in a changing environment. Ciba Found Symp. 1997;206:90-9; discussion 99-105, 106-10. doi: 10.1002/9780470515334.ch6.
- Background: PubMed 8590330Levitt RC, Holroyd KJ. Fine-structure mapping of genes providing susceptibility to asthma on chromosome 5q31-q33. Clin Exp Allergy. 1995 Nov;25 Suppl 2:119-23. doi: 10.1111/j.1365-2222.1995.tb00439.x. No abstract available.
- Background: PubMed 7666875Postma DS, Bleecker ER, Amelung PJ, Holroyd KJ, Xu J, Panhuysen CI, Meyers DA, Levitt RC. Genetic susceptibility to asthma--bronchial hyperresponsiveness coinherited with a major gene for atopy. N Engl J Med. 1995 Oct 5;333(14):894-900. doi: 10.1056/NEJM199510053331402.
- Background: PubMed 7613035DiSilvestre D, Kleeberger SR, Johns J, Levitt RC. Structure and DNA sequence of the mouse MnSOD gene. Mamm Genome. 1995 Apr;6(4):281-4. doi: 10.1007/BF00352417.
- Background: PubMed 7607699Monitto CL, Levitt RC, DiSilvestre D, Holroyd KJ. Localization of the A3 adenosine receptor gene (ADORA3) to human chromosome 1p. Genomics. 1995 Apr 10;26(3):637-8. doi: 10.1016/0888-7543(95)80194-q. No abstract available.
- Background: PubMed 7599858Meyers DA, Bleecker ER. Approaches to mapping genes for allergy and asthma. Am J Respir Crit Care Med. 1995 Jul;152(1):411-3. doi: 10.1164/ajrccm.152.1.7599858. No abstract available.
- Background: PubMed 7735612Levitt RC, Ewart SL. Genetic susceptibility to atracurium-induced bronchoconstriction. Am J Respir Crit Care Med. 1995 May;151(5):1537-42. doi: 10.1164/ajrccm.151.5.7735612.
- Background: PubMed 7698760Levitt RC, Kiser MB, Dragwa C, Jedlicka AE, Xu J, Meyers DA, Hudson JR. Fluorescence-based resource for semiautomated genomic analyses using microsatellite markers. Genomics. 1994 Nov 15;24(2):361-5. doi: 10.1006/geno.1994.1628.
- Background: PubMed 7959791Schwengel DA, Jedlicka AE, Nanthakumar EJ, Weber JL, Levitt RC. Comparison of fluorescence-based semi-automated genotyping of multiple microsatellite loci with autoradiographic techniques. Genomics. 1994 Jul 1;22(1):46-54. doi: 10.1006/geno.1994.1344.
- Background: PubMed 20020171He P, Ma Y, Zhao G, Dai H, Li H, Chang L, Zhang Z. FaRE1: a transcriptionally active Ty1-copia retrotransposon in strawberry. J Plant Res. 2010 Sep;123(5):707-14. doi: 10.1007/s10265-009-0290-0. Epub 2009 Dec 18.
- Background: PubMed 10090967Howard TD, Bleecker ER, Stine OC. Fluorescent allele-specific PCR (FAS-PCR) improves the reliability of single nucleotide polymorphism screening. Biotechniques. 1999 Mar;26(3):380-1. doi: 10.2144/99263bm01. No abstract available.
- Background: PubMed 9641604Stine OC, Xu J, Meyers DA, Bleecker ER. Approaches to fine mapping in asthma. Clin Exp Allergy. 1998 Apr;28 Suppl 1:98-100; discussion 108-10. doi: 10.1046/j.1365-2222.1998.0280s1098.x. No abstract available.
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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.
Deborah Meyers
Wake Forest University
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005359, which also lists 30 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 12 Jul 2016.