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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:
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

April 13, 2007
December 18, 2012
August 2006
June 2010   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00461227 on ClinicalTrials.gov Archive Site
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Effect of Heredity and Environment on Asthma Development and Severity in Puerto Rican Children
Genes, Home Allergens, and Asthma in Puerto Rican Children

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Serum

Probability Sample

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.

  • Asthma
  • Hypersensitivity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1127
June 2010
June 2010   (final data collection date for primary outcome measure)

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])
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT00461227
1353, R01HL079966-01A2, R01 HL079966-01A2
No
Juan Celedon, MD, University of Pittsburgh
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Juan C. Celedon, MD, DrPH Brigham and Women's Hospital
University of Pittsburgh
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP