Systems Pharmacology Approach to Uncontrolled Pediatric Asthma

Summary

Background:

Asthma is a heterogeneous respiratory disease and the most common chronic disease in children. A small subset of children has continuous poor asthma control despite appropriate adherence to asthma medication. There is a clinical need to identify these children as early as possible to optimize treatment and/or to find therapeutic alternatives. Therefore, the "Systems Pharmacology approach to uncontrolled Pediatric Asthma" (SysPharmPediA) study was set up.

Objective:

To establish a cohort of pediatric moderate-to-severe uncontrolled and controlled patients with asthma in order to investigate pathophysiological mechanisms underlying uncontrolled moderate-to-severe asthma in children on maintenance treatment, using a multi-omics systems medicine approach.

Methods:

In this multicenter observational case-control study, moderate-to-severe asthmatic children (n=145, age 6-17 years), were included in specialized hospitals in four European countries (Netherlands, Germany, Spain and Slovenia). Recruited subjects were selected based on good asthma control (controlled asthmatics, n=54) or poor asthma control / recurrent exacerbations (uncontrolled asthmatics, n=91). Comprehensive details concerning demographics, current and past patient/family history and clinical characteristics were collected. In addition, systems-wide omics layers, including epi(genomics), transcriptomics, microbiome, proteomics and metabolomics will be evaluated from multiple collected, relatively non-invasive, samples of from the recruited individuals, such as: blood, feces, saliva, nasal swabs and exhaled breath. Follow-up visits were performed 6 and 12 months after inclusion.

Conditions

• Pediatric Asthma
• Uncontrolled Asthma

Sponsors & Collaborators

• University of Maribor, Maribor, Slovenia.

  collaborator UNKNOWN

• University Children's Hospital, University of Regensburg, Regensburg, Germany

  collaborator UNKNOWN

• Universidad de La Laguna, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain.

  collaborator UNKNOWN

• University of the Basque Country (UPV/EHU)

  collaborator OTHER

• Hospital Universitario Donostia, San Sebastián, Spain.

  collaborator UNKNOWN

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Utrecht University, Utrecht, the Netherlands.

  collaborator UNKNOWN

• Karolinska Institutet

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-12

Primary Completion

2019-10-31

Completion

2020-10-31

Countries

• Germany
• Netherlands
• Slovenia
• Spain
• Sweden

Study Locations