Stress and Treatment Response in Puerto Rican Children With Asthma

NCT03134755 | Completed

• 2 other identifiers: PRO17030493R01HL117191
• Study Type: observational
• Target: 249
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Asthma in Children

Keywords

Asthma; Children; Stress; Puerto Rican; Health disparities; Treatment response; African American

Outcome Measures

Primary Outcomes (3)

• Bronchodilator response (BDR)

  BDR will be measured as the change in forced expiratory volume in 1 second (FEV1) after administration of a short-acting bronchodilator (albuterol)

  15 minutes

• Response to inhaled corticosteroids (ICS)

  ICS response will be measured as change in forced expiratory volume in 1 second (FEV1) and as change in the xhild-Asthma Control Test (C-ACT) score, following six weeks of ICS administration

  Six weeks

• DNA methylation and gene expression differences

  The investigators will examine whether child stress is associated with DNA methylation or gene expression differences, and such differences will then be tested for association with BDR or ICS response (measured as above)

  Six weeks

Study Arms (1)

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)

Drug: Inhaled corticosteroid (mometasone)

Interventions

Inhaled corticosteroid (mometasone) DRUG

The investigators are not measuring the effect of the intervention (ICS), but rather the effect of stress (which is not being intervened on), and this is thus an observational study. The ICS is given to children with asthma in whom an ICS is clinically indicated

Also known as: Asmanex

Study cohort (all children with asthma)

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

300 Puerto Rican and African American children with mild to moderate persistent asthma, ages 8 to 20 years. Of these children, 150 (all Puerto Rican) will be recruited in the metropolitan area of San Juan and Caguas (Puerto Rico), and 150 (all African American) will be recruited in Pittsburgh (PA).

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Behavioral Sciences Research Institute, University of Puerto Rico

San Juan, PR, 00936, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal epithelial samples for DNA and RNA extraction

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Juan C Celedon, MD, DrPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: May 15, 2018
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); PR (1)