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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47728
Enrollment
50
Registered
2017-01-25
Start date
2018-01-26
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma chronic airway inflammation

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: - Recent use of a course of antibiotics (

Design outcomes

Primary

MeasureTime frame
Difference in biomarker profiles (breathomics, microbiomics, metabolomics, epigenomics and [pharmaco]genomics), between children responding to treatment and children not responding to treatment.

Secondary

MeasureTime frame
We will compare the biomarkers profiles of cases during an exacerbation and controls, as well as the profiles within subjects (during and after exacerbation). Construction of the -omics algorithm to predict ICS response

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)