Stress and Treatment Response in Puerto Rican Children With Asthma
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This study aims to first determine whether high child stress leads to reduced response to common treatmenIs for asthma (inhaled corticosteroids and short-acting bronchodilators), and then to identify DNA methylation differences leading to stress-induced treatment resistance among children with asthma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 20
Healthy Volunteers: f
View:
• Physician-diagnosed asthma
• BDR ≥8%99 or (if BDR\<8%) increased airway responsiveness to methacholine (PD20 \<16.81 umol)
• Four Puerto Rican grandparents
• Steroid naïve (no treatment with ICS, nasal, or oral corticosteroids in the prior 4 weeks)
• Parental consent and child's assent to participate in the study
Locations
United States
Pennsylvania
UPMC Children's Hospital of Pittsburgh
Pittsburgh
Other Locations
Puerto Rico
Behavioral Sciences Research Institute, University of Puerto Rico
San Juan
Time Frame
Start Date: 2018-05-15
Completion Date: 2022-05-18
Participants
Target number of participants: 249
Treatments
Study cohort (all children with asthma)
300 children with asthma will receive the same inhaled corticosteroid (ICS) for six weeks, in order to assess response to ICS.Bronchodilator response will be measured before and after ICS therapy. Stress levels (the exposure of interest) will be assessed with a validated questionnaire, before ICS administration (thus, it is an observational study of whether stress is related to treatment response)
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)