Asthma and the Impact of Stress on Treatment Response: The STAR Study

Stress and Treatment Response in Puerto Rican Children with Asthma (STAR)

Protocol Description

The objectives of this study are to determine whether high stress leads to reduced response to common treatments for asthma, such as inhaled corticosteroids and short-acting bronchodilators, and to then identify the genetic and epigenetic mechanisms for treatment resistance. Asthma is the most common chronic disease among children, and Puerto Ricans have the highest burden from asthma of all people in the United States.

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to Puerto Rican children of both genders, ages 9 to 14 years, who have a confirmed diagnosis of mild to moderate persistent asthma.
Boys and Girls: Ages 9 to 14 years

Requirements

Study visits will take place at the Medical Science Campus of the University of Puerto Rico in San Juan. The initial screening visit will include a physical examination and respiratory testing, as well as a questionnaire to help researchers assess the child’s level of stress. Follow-up visits for testing, including blood work and additional surveys, will be done at weeks 1, 3 and 7. At the second visit (week 1), participants will be given an inhaled medication for treatment of asthma and instruction in daily use.
Visits: 4
Duration: 7 to 8 weeks

Status: Open to Enrollment

Source(s) of Support

National Heart, Lung, and Blood Institute
University of Pittsburgh
University of Puerto Rico

Primary Investigator

At Children’s Hospital of Pittsburgh of UPMC
Juan C. Celedón, MD, DrPH

At the University of Puerto Rico
Glorisa Canino, PhD

Contact Information

For more information about the study or enrollment, please contact:

At Children’s Hospital of Pittsburgh of UPMC
Liz Hartigan, Research Coordinator
412-692-7060

At the Medical Science Campus of the University of Puerto Rico
Sonia Delgado, Study Coordinator, or Edna Acosta-Perez, Co-Investigator
787-758-2525, Ext. 2129