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AsthmaNCT00021840

Genetic Epidemiology of Asthma in Costa Rica

An observational study of Asthma and Lung Diseases, run by Brigham and Women's Hospital at 1 site in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To identify genetic factors that influence the development of asthma in Hispanics. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for
Asthma, Lung Diseases
How many people
4,245 participants
Where
1 siteCosta Rica
Study dates
Jul 2001to Jul 2011
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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Homogeneous Hispanic population from the Central Valley of Costa Rica

Who may be able to join

  • A family will be eligible for inclusion in this study only if the asthmatic proband in that family meets all of the following criteria. Each proband must:
  • Be at least 6 years of age
  • Have a physician diagnosis of asthma and either >/= 2 respiratory symptoms or a history of recurrent asthma attacks
  • Have either airway hyperresponsiveness to methacholine (PD20 </= 16 mg/ml) or (if the FEV1 is </= 65% of predicted) a significant bronchodilator response (an increase of at least 12% from baseline FEV1)
  • Have at least 6 great-grandparents born in the Central Valley of Costa Rica
  • Have his/her parents give voluntary written consent to participate in the study
Show all 10Show fewer
  • Give his/her assent to participate in the study.
  • Have at least 2 siblings with physician-diagnosed asthma and no more than one parent with a physician diagnosis of asthma
  • All first- and second-degree relatives of the proband, affected and unaffected will be enrolled in the study of 15 large, multigenerational family pedigrees if available and willing to participate.
  • The natural mother and father of the proband will be enrolled in the study of 600 parent-child trios if available and willing to participate.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply. Each subject must not:
  • Be adopted
  • Have a chronic respiratory disorder other than asthma (e.g., active tuberculosis, bronchiectasis). Inactive tuberculosis is not an exclusion criterion
  • For the study of large, multigenerational pedigrees only: Have a familial relationship to any of the remaining fourteen (14) families over the last four generations.
  • Subject reconsideration for Inclusion
  • Subjects fulfilling the following exclusion criteria below may be eligible for inclusion in the study at a later date provided that the study physician does not feel that their participation will adversely influence the results of the study.
  • 1. Subjects who have taken antibiotics for respiratory disease within one month or have had respiratory infection within 6 weeks of the visit.

Trial locations and contacts

1 site in 1 country.

Costa Rica1 site

  • Hospital Nacional de Ninos

    San José

Other trials in Costa Rica

About this study

To identify genetic factors that influence the development of asthma in Hispanics.

Read the detailed description

BACKGROUND:

Asthma is a major public health problem in the United States, with particularly high prevalence rates among some Hispanic groups. Genetic linkage studies of this disease are of potentially great utility for the identification of those at risk, the search for new pharmaceutical treatments, and designing interventions to prevent development of asthma. Study power is greatly enhanced if a relatively isolated, homogeneous population with a significant prevalence of asthma can be identified. Such a population does not exist among Hispanics in the United States but is available in the Central Valley of Costa Rica.

DESIGN NARRATIVE:

The study concentrates on a genetically isolated Hispanic population with high asthma prevalence living in the Central Valley of Costa Rica. A genome screen will be conducted on large pedigrees multiplex for asthma and linkage analysis performed for seven intermediate phenotypes related to asthma including airway responsiveness; FEV1; bronchodilator responsiveness; skin test reactivity to common aeroallergens; serum total and allergen-specific IgE; and peripheral blood eosinophil count. A genome screen will also be conducted in the parent-child trios, and ancestral haplotypes will be reconstructed to identify regions influencing asthma-associated phenotypes. Within candidate regions demonstrating both linkage in extended pedigrees to asthma and/or asthma-related phenotypes and significant linkage disequilibrium within the unrelated asthmatic subjects, fine mapping will be performed by testing for genetic association to single nucleotide polymorphisms within positional candidate genes.

Medical subject headings
Asthma, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00021840
Study groupRoleWhat they receive
Homogen Hispanic pop/Cent Valley CRAHomogeneous Hispanic population from the Central Valley of Costa Rica

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma diagnosis and asthma morbidity

    Measured: Baseline/entry to study

Secondary outcomes (1)

  1. Lung function measures

    Includes lung function measures via spirometry, pre-/post-bronchodilator (BD) results, methacholine challenge results, specific IgE measurements, exposure measurements (e.g., house dust samples/allergens, endotoxin levels in house dust, questionnaire-based exposures to smoking, pets, siblings, etc.)

    Measured: 11 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2001 (estimated)
  2. Study startJul 2001
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Family based
Time perspective
Cross-sectional
Enrolment
4,245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00021840
Sponsor's protocol ID
971
Other IDs
R37HL066289
Status last verified
Aug 2014
First submitted
7 Aug 2001
Last updated
4 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • Duan QL, Lasky-Su J, Himes BE, Qiu W, Litonjua AA, Damask A, Lazarus R, Klanderman B, Irvin CG, Peters SP, Hanrahan JP, Lima JJ, Martinez FD, Mauger D, Chinchilli VM, Soto-Quiros M, Avila L, Celedon JC, Lange C, Weiss ST, Tantisira KG. A genome-wide association study of bronchodilator response in asthmatics. Pharmacogenomics J. 2014 Feb;14(1):41-7. doi: 10.1038/tpj.2013.5. Epub 2013 Mar 19.

    PubMed 23508266

  • Melen E, Granell R, Kogevinas M, Strachan D, Gonzalez JR, Wjst M, Jarvis D, Ege M, Braun-Fahrlander C, Genuneit J, Horak E, Bouzigon E, Demenais F, Kauffmann F, Siroux V, Michel S, von Berg A, Heinzmann A, Kabesch M, Probst-Hensch NM, Curjuric I, Imboden M, Rochat T, Henderson J, Sterne JA, McArdle WL, Hui J, James AL, William Musk A, Palmer LJ, Becker A, Kozyrskyj AL, Chan-Young M, Park JE, Leung A, Daley D, Freidin MB, Deev IA, Ogorodova LM, Puzyrev VP, Celedon JC, Brehm JM, Cloutier MM, Canino G, Acosta-Perez E, Soto-Quiros M, Avila L, Bergstrom A, Magnusson J, Soderhall C, Kull I, Scholtens S, Marike Boezen H, Koppelman GH, Wijga AH, Marenholz I, Esparza-Gordillo J, Lau S, Lee YA, Standl M, Tiesler CM, Flexeder C, Heinrich J, Myers RA, Ober C, Nicolae DL, Farrall M, Kumar A, Moffatt MF, Cookson WO, Lasky-Su J. Genome-wide association study of body mass index in 23 000 individuals with and without asthma. Clin Exp Allergy. 2013 Apr;43(4):463-74. doi: 10.1111/cea.12054.

    PubMed 23517042

  • Levin AM, Mathias RA, Huang L, Roth LA, Daley D, Myers RA, Himes BE, Romieu I, Yang M, Eng C, Park JE, Zoratti K, Gignoux CR, Torgerson DG, Galanter JM, Huntsman S, Nguyen EA, Becker AB, Chan-Yeung M, Kozyrskyj AL, Kwok PY, Gilliland FD, Gauderman WJ, Bleecker ER, Raby BA, Meyers DA, London SJ, Martinez FD, Weiss ST, Burchard EG, Nicolae DL, Ober C, Barnes KC, Williams LK. A meta-analysis of genome-wide association studies for serum total IgE in diverse study populations. J Allergy Clin Immunol. 2013 Apr;131(4):1176-84. doi: 10.1016/j.jaci.2012.10.002. Epub 2012 Nov 10.

    PubMed 23146381

  • Myers RA, Himes BE, Gignoux CR, Yang JJ, Gauderman WJ, Rebordosa C, Xie J, Torgerson DG, Levin AM, Baurley J, Graves PE, Mathias RA, Romieu I, Roth LA, Conti D, Avila L, Eng C, Vora H, LeNoir MA, Soto-Quiros M, Liu J, Celedon JC, Galanter JM, Farber HJ, Kumar R, Avila PC, Meade K, Serebrisky D, Thyne S, Rodriguez-Cintron W, Rodriguez-Santana JR, Borrell LN, Lemanske RF Jr, Bleecker ER, Meyers DA, London SJ, Barnes KC, Raby BA, Martinez FD, Gilliland FD, Williams LK, Burchard EG, Weiss ST, Nicolae DL, Ober C. Further replication studies of the EVE Consortium meta-analysis identifies 2 asthma risk loci in European Americans. J Allergy Clin Immunol. 2012 Dec;130(6):1294-301. doi: 10.1016/j.jaci.2012.07.054. Epub 2012 Oct 4.

    PubMed 23040885

  • Forno E, Lasky-Su J, Himes B, Howrylak J, Ramsey C, Brehm J, Klanderman B, Ziniti J, Melen E, Pershagen G, Wickman M, Martinez F, Mauger D, Sorkness C, Tantisira K, Raby BA, Weiss ST, Celedon JC. Genome-wide association study of the age of onset of childhood asthma. J Allergy Clin Immunol. 2012 Jul;130(1):83-90.e4. doi: 10.1016/j.jaci.2012.03.020. Epub 2012 May 2.

    PubMed 22560479

  • Himes BE, Klanderman B, Ziniti J, Senter-Sylvia J, Soto-Quiros ME, Avila L, Celedon JC, Lange C, Mariani TJ, Lasky-Su J, Hersh CP, Raby BA, Silverman EK, Weiss ST, DeMeo DL. Association of SERPINE2 with asthma. Chest. 2011 Sep;140(3):667-674. doi: 10.1378/chest.10-2973. Epub 2011 Mar 24.

    PubMed 21436250

  • Torgerson DG, Ampleford EJ, Chiu GY, Gauderman WJ, Gignoux CR, Graves PE, Himes BE, Levin AM, Mathias RA, Hancock DB, Baurley JW, Eng C, Stern DA, Celedon JC, Rafaels N, Capurso D, Conti DV, Roth LA, Soto-Quiros M, Togias A, Li X, Myers RA, Romieu I, Van Den Berg DJ, Hu D, Hansel NN, Hernandez RD, Israel E, Salam MT, Galanter J, Avila PC, Avila L, Rodriquez-Santana JR, Chapela R, Rodriguez-Cintron W, Diette GB, Adkinson NF, Abel RA, Ross KD, Shi M, Faruque MU, Dunston GM, Watson HR, Mantese VJ, Ezurum SC, Liang L, Ruczinski I, Ford JG, Huntsman S, Chung KF, Vora H, Li X, Calhoun WJ, Castro M, Sienra-Monge JJ, del Rio-Navarro B, Deichmann KA, Heinzmann A, Wenzel SE, Busse WW, Gern JE, Lemanske RF Jr, Beaty TH, Bleecker ER, Raby BA, Meyers DA, London SJ; Mexico City Childhood Asthma Study (MCAAS); Gilliland FD; Children's Health Study (CHS) and HARBORS study; Burchard EG; Genetics of Asthma in Latino Americans (GALA) Study, Study of Genes-Environment and Admixture in Latino Americans (GALA2) and Study of African Americans, Asthma, Genes & Environments (SAGE); Martinez FD; Childhood Asthma Research and Education (CARE) Network; Weiss ST; Childhood Asthma Management Program (CAMP); Williams LK; Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE); Barnes KC; Genetic Research on Asthma in African Diaspora (GRAAD) Study; Ober C, Nicolae DL. Meta-analysis of genome-wide association studies of asthma in ethnically diverse North American populations. Nat Genet. 2011 Jul 31;43(9):887-92. doi: 10.1038/ng.888.

    PubMed 21804549

  • Hunninghake GM, Soto-Quiros ME, Avila L, Kim HP, Lasky-Su J, Rafaels N, Ruczinski I, Beaty TH, Mathias RA, Barnes KC, Wilk JB, O'Connor GT, Gauderman WJ, Vora H, Baurley JW, Gilliland F, Liang C, Sylvia JS, Klanderman BJ, Sharma SS, Himes BE, Bossley CJ, Israel E, Raby BA, Bush A, Choi AM, Weiss ST, Celedon JC. TSLP polymorphisms are associated with asthma in a sex-specific fashion. Allergy. 2010 Dec;65(12):1566-75. doi: 10.1111/j.1398-9995.2010.02415.x.

    PubMed 20560908

  • Forno E, Fuhlbrigge A, Soto-Quiros ME, Avila L, Raby BA, Brehm J, Sylvia JM, Weiss ST, Celedon JC. Risk factors and predictive clinical scores for asthma exacerbations in childhood. Chest. 2010 Nov;138(5):1156-65. doi: 10.1378/chest.09-2426. Epub 2010 May 14.

    PubMed 20472862

  • Himes BE, Lasky-Su J, Wu AC, Wilk JB, Hunninghake GM, Klanderman B, Murphy AJ, Lazarus R, Soto-Quiros ME, Avila L, Celedon JC, Lange C, O'Connor GT, Raby BA, Silverman EK, Weiss ST. Asthma-susceptibility variants identified using probands in case-control and family-based analyses. BMC Med Genet. 2010 Aug 10;11:122. doi: 10.1186/1471-2350-11-122.

    PubMed 20698975

  • Sharma S, Tantisira K, Carey V, Murphy AJ, Lasky-Su J, Celedon JC, Lazarus R, Klanderman B, Rogers A, Soto-Quiros M, Avila L, Mariani T, Gaedigk R, Leeder S, Torday J, Warburton D, Raby B, Weiss ST. A role for Wnt signaling genes in the pathogenesis of impaired lung function in asthma. Am J Respir Crit Care Med. 2010 Feb 15;181(4):328-36. doi: 10.1164/rccm.200907-1009OC. Epub 2009 Nov 19.

    PubMed 19926868

  • Bunyavanich S, Soto-Quiros ME, Avila L, Laskey D, Senter JM, Celedon JC. Risk factors for allergic rhinitis in Costa Rican children with asthma. Allergy. 2010 Feb;65(2):256-63. doi: 10.1111/j.1398-9995.2009.02159.x. Epub 2009 Oct 1.

    PubMed 19796208

  • Hunninghake GM, Cho MH, Tesfaigzi Y, Soto-Quiros ME, Avila L, Lasky-Su J, Stidley C, Melen E, Soderhall C, Hallberg J, Kull I, Kere J, Svartengren M, Pershagen G, Wickman M, Lange C, Demeo DL, Hersh CP, Klanderman BJ, Raby BA, Sparrow D, Shapiro SD, Silverman EK, Litonjua AA, Weiss ST, Celedon JC. MMP12, lung function, and COPD in high-risk populations. N Engl J Med. 2009 Dec 31;361(27):2599-608. doi: 10.1056/NEJMoa0904006. Epub 2009 Dec 16.

    PubMed 20018959

  • Verlaan DJ, Berlivet S, Hunninghake GM, Madore AM, Lariviere M, Moussette S, Grundberg E, Kwan T, Ouimet M, Ge B, Hoberman R, Swiatek M, Dias J, Lam KC, Koka V, Harmsen E, Soto-Quiros M, Avila L, Celedon JC, Weiss ST, Dewar K, Sinnett D, Laprise C, Raby BA, Pastinen T, Naumova AK. Allele-specific chromatin remodeling in the ZPBP2/GSDMB/ORMDL3 locus associated with the risk of asthma and autoimmune disease. Am J Hum Genet. 2009 Sep;85(3):377-93. doi: 10.1016/j.ajhg.2009.08.007.

    PubMed 19732864

  • Murphy A, Tantisira KG, Soto-Quiros ME, Avila L, Klanderman BJ, Lake S, Weiss ST, Celedon JC. PRKCA: a positional candidate gene for body mass index and asthma. Am J Hum Genet. 2009 Jul;85(1):87-96. doi: 10.1016/j.ajhg.2009.06.011. Epub 2009 Jul 2.

    PubMed 19576566

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Lung Diseases, run by Brigham and Women's Hospital at 1 site in Costa Rica.

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 10 inclusion and 7 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 4 Aug 2014. 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 Costa Rica. 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?

Asthma diagnosis and asthma morbidity (time frame: Baseline/entry to study). 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 NCT00021840, which also lists 38 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 4 Aug 2014.

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