Study design
The SysPharmPediA study is a multicenter European observational study
with a case-control setting. The study design and study population were
described previously in detail by Abdel-Aziz et al. 18Briefly, children aged 6-17 with doctor-diagnosed moderate-to-severe
asthma were included at tertiary hospitals from four European countries:
the Netherlands, Germany, Spain, and Slovenia. This study with
registration identifier NCT04865575 (at
www.clinicaltrials.gov) was
carried out based on the Helsinki Declaration and approved by the
medical ethics committee of the University Medical Center Utrecht, the
Netherlands (NL55788.041.15); National Medical Ethics Committee,
Slovenia (0120–569/2017/4), the ethics committee of University
Regensburg, Germany (18–1034–101); Clinical Research Ethics Committee
of the Basque Country, Spain (PI2015075); All participants or their
caretaker or parents gave their informed consent.