NCT00106470

Brief Summary

The purpose of this study is to examine genetic factors that influence the development of chronic obstructive pulmonary disease (COPD) in Hispanics, a minority group at high risk for the disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
679

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

4.9 years

First QC Date

March 24, 2005

Last Update Submit

December 12, 2012

Conditions

Keywords

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Genetic factors that influence the development of COPD in Hispanics.

    Measured through the use of genetic samples

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Families of individuals with physician-diagnosed COPD and smoking-related airflow obstruction who are younger than 71 years.

You may qualify if:

  • COPD
  • Reduced FEV1 after administration of bronchodilator (less than or equal to 60% of predicted value)
  • At least six great-grandparents born in the Central Valley of Costa Rica
  • At least one sibling with a history of smoking (10 or more packs per year)

You may not qualify if:

  • Chronic respiratory disorder other than COPD (as determined by a questionnaire and high-resolution CT chest scan)
  • Severe alpha 1-antitrypsin deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional de Niños

San José, Costa Rica

Location

Related Publications (3)

  • Hunninghake GM, Weiss ST, Celedon JC. Asthma in Hispanics. Am J Respir Crit Care Med. 2006 Jan 15;173(2):143-63. doi: 10.1164/rccm.200508-1232SO. Epub 2005 Oct 6.

    PMID: 16210666BACKGROUND
  • Brehm JM, Celedon JC. Chronic obstructive pulmonary disease in Hispanics. Am J Respir Crit Care Med. 2008 Mar 1;177(5):473-8. doi: 10.1164/rccm.200708-1274PP. Epub 2007 Nov 20.

    PMID: 18029789BACKGROUND
  • Brehm JM, Hagiwara K, Tesfaigzi Y, Bruse S, Mariani TJ, Bhattacharya S, Boutaoui N, Ziniti JP, Soto-Quiros ME, Avila L, Cho MH, Himes B, Litonjua AA, Jacobson F, Bakke P, Gulsvik A, Anderson WH, Lomas DA, Forno E, Datta S, Silverman EK, Celedon JC. Identification of FGF7 as a novel susceptibility locus for chronic obstructive pulmonary disease. Thorax. 2011 Dec;66(12):1085-90. doi: 10.1136/thoraxjnl-2011-200017. Epub 2011 Sep 15.

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juan C. Celedon, MD, DrPH

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2005

First Posted

March 25, 2005

Study Start

February 1, 2005

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations