Stress and Treatment Response in Puerto Rican Children With Asthma

Completed

Conditions studied: Asthma in Children

In brief

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.

Key facts

Study ID

NCT03134755

Run by

University of Pittsburgh

People needed

249

Starts

2018-05-15

Expected to finish

2022-05-18

Last updated by the study team

2025-02-11

Who can join

Age: 8 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Chronic disease (i.e. respiratory, liver, cardiac, renal, neurologic) other than asthma
• Severe asthma, as evidenced by: a) intubation for asthma at any time, or b) ≥3 hospitalizations or ≥6 visits to the emergency department/urgent care in the previous year, or c) chronic/continuous need for medications other than single controller therapy [ICS or leukotriene inhibitors] and short-acting β2-agonists
• Current smoking or former smoking if ≥5 pack-years
• Inability to perform acceptable spirometry
• FEV1 <60% of predicted

Where it is running

• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Behavioral Sciences Research Institute, University of Puerto Rico — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

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