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Effect of Heredity and Environment on Asthma Development and Severity in Puerto Rican Children

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Juan Celedon, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00461227
First received: April 13, 2007
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Asthma
Hypersensitivity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genes, Home Allergens, and Asthma in Puerto Rican Children

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Effect of certain genes and allergens on the development and severity of asthma in Puerto Rican children [ Time Frame: Measured at participants' two study visits ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Enrollment: 1127
Study Start Date: August 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Asthma is a chronic disease that causes constriction of the airways. People with asthma may experience wheezing, coughing, chest tightness, and trouble breathing. Although asthma is a major public health problem among Puerto Ricans, little research has been done to determine the influence of heredity and environment on the disease in this population. To learn more about these relationships, this study will examine the effects of certain genes and allergens on the development and severity of asthma in Puerto Rican children.

This observational study will recruit both children with asthma and children without asthma. Participants will meet with study staff twice during the study. The first visit will take place at participants' homes. Participants will complete questionnaires about demographics, respiratory and general health, and household characteristics. Lung function testing, collection of blood samples, and collection of household dust samples will also take place at the home-based visit. The second visit will take place at the study site. At this visit, participants will undergo allergy tests on the skin and a methacholine challenge test to assess their airway responsiveness and asthma severity. The methacholine challenge test will involve inhaling mist through a mouthpiece and blowing forcefully into a special apparatus called a spirometer. Parents will be asked to provide information about their children's exposure to pets in early life. Each visit will last approximately 1.5 hours and will be scheduled close to the date on which a participant enters the study.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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])
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461227

Locations
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Juan C. Celedon, MD, DrPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Juan Celedon, MD, Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00461227     History of Changes
Other Study ID Numbers: 1353, R01HL079966-01A2, R01 HL079966-01A2
Study First Received: April 13, 2007
Last Updated: December 18, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Puerto Rican
Allergies

Additional relevant MeSH terms:
Asthma
Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013