Pediatric AsthmaNCT04865575
Systems Pharmacology Approach to Uncontrolled Pediatric Asthma
An observational study of Pediatric Asthma and Uncontrolled Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Asthma, Uncontrolled Asthma
- How many people
- 145 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 12 Jan 2018to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Four tertiary care centers from four European countries (the Netherlands, Germany, Spain, and Slovenia) recruited 145 asthmatic children and adolescents (6-17 years old). All centers obtained approval from their local medical ethics committee (ethics committee of University Regensburg, Germany (18-1034-101); Clinical Research Ethics Committee of the Basque Country, Spain (PI2015075 (SO)); Medical Ethics Committee of the University Medical Center Utrecht (UMC Utrecht), Utrecht, the Netherlands (NL55788.041.15); National Medical Ethics Committee, Slovenia (0120-569/2017/4)) and written informed consents were collected from the parents/caregivers and/or the recruited children when appropriate.
Who may be able to join
- 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):
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Spain2 sites
University of the Basque Country
San Sebastián
Universidad de La Laguna
Santa Cruz de Tenerife
About this study
Official title: Systems Pharmacology Approach to Uncontrolled Pediatric Asthma (SysPharmPediA)
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.
Read more
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
- Keywords
- Systems Pharmacology, Omics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| controlled asthmatics | moderate-to-severe asthmatic children with good asthma control | |
| uncontrolled asthmatics | moderate-to-severe asthmatic children with poor asthma control / recurrent exacerbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva and stool microbiome
Differences in 16S rRNA microbial α- and ß- diversities between cases and controls
Measured: Baseline
Exhaled breath metabolome
Differences in presence and levels of volatile organic compounds between cases and controls
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start12 Jan 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maribor, Maribor, Slovenia., University of Regensburg, Universidad de La Laguna, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain., University of the Basque Country (UPV/EHU), Hospital Universitario Donostia, San Sebastián, Spain., Instituto de Salud Carlos III, Utrecht University, Utrecht, the Netherlands., Karolinska Institutet
- Responsible party
- Principal investigator, Prof. dr. A.H. Maitland-van der Zee, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865575
- Sponsor's protocol ID
- NL55788.041.15
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In case other researchers are interested to work with data that is collected within SysPharmPediA; we kindly request to contact the PI of the study (Prof. dr. A.H. Maitland-van der Zee - a.h.maitland@amsterdamumc.nl) 1. The PIs will refer to an up-to-list of planned publications, which includes ongoing and planned analysis work from SysPharmPediA partners and from those granted access to specific data, to determine potential duplication of work. 2. To understand and draw sound scientific results those groups planning to work on SysPharmPediA data should engage with the SysPharmPediA members who have generated the data in question. 3. A summary of the Data Analysis Plan (DAP) must be attached to the data access request form. 4. If the analysis deviates substantially from the summary DAP or provides results which the SysPharmPediA group feel mis-represent the data, the SysPharmPediA group may raise an objection with the publication concerned.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Pharmacology Approach to Uncontrolled Pediatric Asthma (SysPharmPediA)
- ClinicalTrials.gov ID
- NCT04865575
- Acronym / sponsor ID
- NL55788.041.15
- Conditions
- Pediatric Asthma, Uncontrolled Asthma
- Keywords
- Systems Pharmacology, Omics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- University of Maribor, Maribor, Slovenia., University of Regensburg, Universidad de La Laguna, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain., University of the Basque Country (UPV/EHU), Hospital Universitario Donostia, San Sebastián, Spain., Instituto de Salud Carlos III, Utrecht University, Utrecht, the Netherlands., Karolinska Institutet
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled asthmatics | – | –moderate-to-severe asthmatic children with good asthma control |
| uncontrolled asthmatics | – | –moderate-to-severe asthmatic children with poor asthma control / recurrent exacerbations |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Four tertiary care centers from four European countries (the Netherlands, Germany, Spain, and Slovenia) recruited 145 asthmatic children and adolescents (6-17 years old). All centers obtained approval from their local medical ethics committee (ethics committee of University Regensburg, Germany (18-1034-101); Clinical Research Ethics Committee of the Basque Country, Spain (PI2015075 (SO)); Medical Ethics Committee of the University Medical Center Utrecht (UMC Utrecht), Utrecht, the Netherlands (NL55788.041.15); National Medical Ethics Committee, Slovenia (0120-569/2017/4)) and written informed consents were collected from the parents/caregivers and/or the recruited children when appropriate.
Key inclusion criteria (16 listed)
- 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):
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Saliva and stool microbiome
Time frame: Baseline
Differences in 16S rRNA microbial α- and ß- diversities between cases and controls
Exhaled breath metabolome
Time frame: Baseline
Differences in presence and levels of volatile organic compounds between cases and controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Undecided. In case other researchers are interested to work with data that is collected within SysPharmPediA; we kindly request to contact the PI of the study (Prof. dr. A.H. Maitland-van der Zee - a.h.maitland@amsterdamumc.nl) 1. The PIs will refer to an up-to-list of planned publications, which includes ongoing and planned analysis work from SysPharmPediA partners and from those granted access to specific data, to determine potential duplication of work. 2. To understand and draw sound scientific results those groups planning to work on SysPharmPediA data should engage with the SysPharmPediA members who have generated the data in question. 3. A summary of the Data Analysis Plan (DAP) must be attached to the data access request form. 4. If the analysis deviates substantially from the summary DAP or provides results which the SysPharmPediA group feel mis-represent the data, the SysPharmPediA group may raise an objection with the publication concerned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Asthma and Uncontrolled Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Germany, Netherlands, Slovenia, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva and stool microbiome (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.