Pediatric Asthma Clinical Trial
Official title:
Systems Pharmacology Approach to Uncontrolled Pediatric Asthma (SysPharmPediA)
Verified date | April 2021 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Germany | University Regensburg | Regensburg | |
Netherlands | Utrecht University | Utrecht | |
Slovenia | University of Maribor | Maribor | |
Spain | University of the Basque Country | San Sebastián | |
Spain | Universidad de La Laguna | Santa Cruz De Tenerife | |
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Hospital Universitario Donostia, San Sebastián, Spain., Instituto de Salud Carlos III, Madrid, Comunidad de Madrid, Spain., Karolinska Institutet, Karolinska Institutet, Stockholm, Sweden, Universidad de La Laguna, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain., University Children's Hospital, University of Regensburg, Regensburg, Germany, University of Maribor, Maribor, Slovenia., University of the Basque Country (UPV/EHU), San Sebastián, Spain., Utrecht University, Utrecht, the Netherlands. |
Germany, Netherlands, Slovenia, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | Age in years | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Sex | Female/Male | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | BMI | kg/m2 | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Uncontrolled asthma | according to the Asthma Control Test (ACT) questionnaire (<19 score) and frequent exacerbation within the past 12 months (>n of exacerbation in the past 12 months | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Exacerbations | Exacerbation requiring OCS use, hospitalization or ER visit | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Spirometry | FEV1 (L, percent predicted value) | Baseline | |
Other | Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered) | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Atopy | Questionnaire on history of allergic diseases | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Current asthma medication intake | ICS: inhaled corticosteroids, LTRA: leukotriene antagonist, SABA: short-acting beta agonist, LABA: long-acting beta agonist, OCS: oral corticosteroids, Omalizumab, Mepolizumab | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Other | Asthma severity | Asthma Control Test (ACT) | Baseline (+ follow-up at 6 and 12 months after baseline inclusion) | |
Primary | Saliva and stool microbiome | Differences in 16S rRNA microbial a- and ß- diversities between cases and controls | Baseline | |
Primary | Exhaled breath metabolome | Differences in presence and levels of volatile organic compounds between cases and controls | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05706571 -
Child Patient End-of-Life Care Module
|
N/A | |
Not yet recruiting |
NCT06379607 -
High Flow Nasal Cannula Rates in Pediatric Asthma
|
N/A | |
Not yet recruiting |
NCT05999032 -
The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
|
N/A | |
Completed |
NCT03933540 -
Association Between Activity and PROMIS Pediatric Measures in Children With Asthma
|
||
Active, not recruiting |
NCT03842033 -
Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
|
N/A | |
Not yet recruiting |
NCT06321471 -
AeviceMD for Pediatric Asthma Management
|
N/A | |
Not yet recruiting |
NCT05826561 -
Developing a Childhood Asthma Risk Passive Digital Marker
|
N/A | |
Recruiting |
NCT05608668 -
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
|
N/A | |
Completed |
NCT03814018 -
Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines
|
||
Recruiting |
NCT06112080 -
Wearable Auscultation Device Validation in Children
|
||
Completed |
NCT01650844 -
School-Based Telemedicine Enhanced Asthma Management
|
N/A | |
Completed |
NCT01326182 -
Intervention for Depressed Latina Mothers of Children With Asthma
|
Phase 2 | |
Recruiting |
NCT06223828 -
Azithromycin for Critical Asthma - Pediatrics
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06278662 -
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
|
N/A | |
Not yet recruiting |
NCT05945355 -
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
|
N/A |