NCT00461227

Brief Summary

Asthma is a major public health problem among Puerto Ricans. Little is known, however, about the effect of heredity and environment on the development and severity of asthma in this population. This study will examine the relationship between asthma and certain genetic and environmental factors in Puerto Rican children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,127

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

3.8 years

First QC Date

April 13, 2007

Last Update Submit

December 18, 2012

Conditions

AsthmaHypersensitivity

Keywords

Puerto RicanAllergies

Outcome Measures

Primary Outcomes (1)

  • Effect of certain genes and allergens on the development and severity of asthma in Puerto Rican children

    Measured at participants' two study visits

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children of Puerto Rican descent (having four Puerto Rican grandparents) living in Hartford (Connecticut) and in the metropolitan areas of San Juan and Caguas in the island of Puerto Rico.

You may qualify if:

  • For participants with asthma:
  • Diagnosis of asthma
  • History of wheezing within 12 months prior to study entry
  • Has four grandparents that were born in Puerto Rico
  • For participants without asthma:
  • No diagnosis of asthma
  • No history of wheezing within 12 months prior to study entry
  • Has four grandparents that were born in Puerto Rico

You may not qualify if:

  • Significant pulmonary disease other than asthma
  • Hospitalization in the neonatal intensive care unit and requiring ventilatory support
  • History of cigarette smoking for more than 5 pack-years (\[number of packs smoked per day\] x \[number of years of smoking\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puerto Rico

San Juan, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

AsthmaHypersensitivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Juan C. Celedon, MD, DrPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

August 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

PR(1)