Status:
COMPLETED
Systems Pharmacology Approach to Uncontrolled Pediatric Asthma
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
University of Maribor, Maribor, Slovenia.
University Children's Hospital, University of Regensburg, Regensburg, Germany
Conditions:
Pediatric Asthma
Uncontrolled Asthma
Eligibility:
All Genders
6-18 years
Brief 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 ...
Eligibility Criteria
Inclusion
- General:
- Between 6-17 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 Paediatricians, 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 (controlled asthma) 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
- ACQ/ACT scores indicating well controlled asthma or few reported asthma symptoms during asthma checks in the past year.
Exclusion
- Recent use of a course of antibiotics (\< 1 month). This will affect the microbiome analyses.
- A patient can be re-screened 1 month after the use of the antibiotic treatment has finished.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04865575
Start Date
January 12 2018
End Date
October 31 2020
Last Update
April 29 2021
Active Locations (6)
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1
University Regensburg
Regensburg, Germany
2
Utrecht University
Utrecht, Netherlands
3
University of Maribor
Maribor, Slovenia
4
University of the Basque Country
San Sebastián, Spain