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OpenTrials
Completed

NCT Number: NCT00461227

Effect of Heredity and Environment on Asthma Development and Severity 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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Puerto Rico

San Juan, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Genes, Home Allergens, and Asthma in Puerto Rican Children

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Apr 17, 2007
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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