SysPharmPediA: Systems pharmacology approach to difficult-to-treat pediatric asthma*

Completed

• Conditions: asthma; chronic airway inflammation; 10001708; 10006436

• Registration Number: NL-OMON47728
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

General:
- Between 6-18 years of age
- Doctor diagnosis of asthma;In addition to the general criteria, a case with uncontrolled asthma (case group A) should meet:
- Asthma treatment Global INitiative of Asthma (GINA) step 3 or higher
- * 1of the following criteria (based on the guideline *Childhood Asthma* of the section paediatric pulmonology of the Dutch Society of Pediatricians, 2007):
- Frequent exacerbations requiring OCS use (*1 in the past year) and/or
- Severe exacerbations requiring hospitalization or ER visits in the past year and/or
- ACQ/ACT scores indicating uncontrolled asthma ;In addition to the general criteria, a case with an acute exacerbation (case group B) should meet:
- Asthma treatment Global INitiative of Asthma (GINA) step 2 or higher
- Current severe asthma exacerbation requiring hospitalization ;In addition to the general inclusion criteria, a control should meet the following criteria:
- Asthma treatment Global INitiative of Asthma (GINA) step 3 or higher
- Lack of severe exacerbations requiring OCS use or hospitalizations or ER visits in the past year

Exclusion Criteria

- Recent use of a course of antibiotics (< 1 month). This will affect the microbiome analyses.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in biomarker profiles (breathomics, microbiomics, metabolomics,<br /><br>epigenomics and [pharmaco]genomics), between children responding to treatment<br /><br>and children not responding to treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will compare the biomarkers profiles of cases during an exacerbation and<br /><br>controls, as well as the profiles within subjects (during and after<br /><br>exacerbation). Construction of the -omics algorithm to predict ICS response</p><br>