Asthma in ChildrenPUFFINNCT03654508
Pharmacogenetics Use For Further Treatment Improvement in childreN
A study testing ADRB2-genotype guided treatment and Randomisation in people with Asthma in Children, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 21 sites in 3 countries.
Trial summary
There is large heterogeneity in treatment response to asthma medication and a one-size fits all approach based on current guidelines might not fit all children with asthma. It is expected that children with one or more variant alleles (Arg16Arg and Arg16Gly) within the beta2 adrenergic receptor (ADRB2) gene coding for… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- ADRB2-genotype guided treatment and Randomisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 12 Jun 2018to 18 Oct 2023
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Doctor's diagnosis of asthma (ever) based on patient history, FEV1 reversibility ≥ 12% and/or bronchial hyperresponsiveness
- Current asthma symptoms (based on ACT (≥12 years) or C-ACT (<12 years) score ≤ 19
- ICS use ≥ 3 months before inclusion (start dosage ICS, treatment step 2 according to childhood asthma guideline NVK, Table 3)
- Adequate inhalation technique (based on validated checklist score [21])
- Self-assessed good adherence to maintenance asthma treatment
- Understanding of Dutch language
- Internet access a home, willing to fill in internet questionnaires
Who cannot join
- Active smoking
- Congenital heart disease
- Serious lung disease other than asthma (Cystic Fibrosis, Primary Ciliary Dyskinesia, congenital lung disorders, severe immune disorders)
- LABA use in past 6 months
- Omalizumab use
- ICU admission in the previous year
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
Netherlands19 sites
VUmc locatie Boelelaan
Amsterdam, North Holland, 1081 HV
Academic Medical Center, Department of Respiratory Disease
Amsterdam-Zuidoost, North Holland, 1105AZ
Rijnstate
Arnhem, Gelderland, 6815 AD
Amphia ziekenhuis
Breda, North Brabant, 4818CK
Reinier de Graaf Gasthuis
Delft, South Holland, 2625 AD
Nij Smellinghe
Drachten, Drenthe, 9202NN
Catharina ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Medisch Spectrum Twente
Enschede, Twente, 7512 KZ
University Medical Center Groningen
Groningen, 9700RB
Martini ziekenhuis
Groningen, 9728NT
Tergooi ziekenhuis
Hilversum, 1213 XZ
Spaarne Gasthuis
Hoofddorp, North Holland, 0031232245730
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934AD
RadboudUMC
Nijmegen, Gelderland, 6525GA
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ
Erasmus Medical Center
Rotterdam, South Holland, 3015CN
Sint Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM
Maasstadziekenhuis
Rotterdam, South Holland, 3079 DZ
Haga ziekenhuis
The Hague, South Holland, 2545 AA
About this study
There is large heterogeneity in treatment response to asthma medication and a one-size fits all approach based on current guidelines might not fit all children with asthma. It is expected that children with one or more variant alleles (Arg16Arg and Arg16Gly) within the beta2 adrenergic receptor (ADRB2) gene coding for the beta2-receptor have a higher risk to poorly respond to long-acting beta2-agonists (LABA) comparing to the Gly16Gly wildtype.
Aims To study whether ADRB2 genotype-guided treatment will lead to improvement in asthma control in children with uncontrolled asthma on inhaled corticosteroids compared with usual care.
Read more
Design A multicentre, double-blind, precision medicine, randomized trial will be carried out within 20 Dutch hospitals. 310 asthmatic children (6-17 years of age) not well controlled on a low dose of inhaled corticosteroids (ICS) will be included and randomized over a genotype-guided and a non-genotype-guided(control) arm. In the genotype-guided arm children with Arg16Arg and Arg16Gly will be treated with double dosages of ICS and with the Gly16Gly wildtype with add on LABA. In the control arm children will be randomized over both treatment options. Lung function measurements, questionnaires focussing on asthma control (ACT/c-ACT) and quality of life, will be obtained in three visits within 6 months. The primary outcome will be improvement in asthma control based on repeated measurement analysis of c-ACT or ACT scores in the first three months of the trial. Additional cost effectiveness studies will be performed.
Conclusion Currently, pharmacogenetics is not used in paediatric asthmas. This trial may pave the way to implement promising results for genotype-guided treatment in paediatric asthma in clinical practice.
Read the detailed description
Study design: national, multi-centre, double-blind randomized controlled trial
Duration: 6 months, with 3 visits in the hospitals (at t=0, t=3 months and t=6 months)
Setting: Patients are recruited at out-patient asthma clinics in secondary and tertiary care hospitals in the Netherlands.
Description: Three hundred ten children (6 to 17 years of age) with a doctor's diagnosis of asthma and uncontrolled asthma symptoms despite adherent and adequate use of ICS for at least three months (step 2 asthma treatment) will be recruited by secondary and tertiary care centers in the Netherlands. All participants are eligible for step-up asthma treatment (from step 2 to step 3) as assessed by the treating paediatrician/paediatric pulmonologist. Participants will be randomized to a genotype-guided treatment arm (n=155) or to a usual care, non-genotype guided arm (n=155) and followed for 6 months.
Genotyping before start treatment During the baseline visit in the hospital, clinical data and biological samples (including a DNA sample) will be collected. Upon this visit, the DNA sample will be send to the Clinical Chemistry department of the Erasmus MC (Head: Prof. R. van Schaik) to perform genotyping of the ADRB2 gene within one week. The treating physician will adapt the treatment regime of the participant based on the treatment advice of the study coordinator (Table 1). For the children in the genotype-arm, this will be based on the genotype. The treating physician will not know (be blinded) whether the treatment advice was based on the genotype (intervention arm) or based on randomization (control arm). The participant will be followed for 6 months. If the participant is still uncontrolled at t=3 months, treatment will be adapted. All children will be genotyped, in order to assess the influence of the genotype on treatment outcome in the usual arm group retrospectively. The children should use the same inhalation device during the study to avoid confusion on how they should inhale their medication.
Furthermore, to test the hypothesis it is necessary to include enough children in the control group with Arg16Arg or Arg16Gly to be treated with LABA. The amount of children treated with LABA and ICS should be equal in the control group. Therefore children are randomized in the control group over doubling ICS (n=77) and adding LABA (n=77). This will lead to an estimated number of children with Arg16Arg or Arg16Gly of 51 who will get LABA add on. In this way the power is high enough to determine the effectivity of both treatment options in the three genotypes. The investigators find it important to define effectivity next to the question whether genotyping benefits children with asthma. In the control group DNA samples will be obtained for retrospective analysis.
It is safe to randomise the children again who are randomised within the control arm, because treatment with a double dose of ICS and adding a LABA are both standard of care. A Cochrane review from 2009 has shown that both treatments have proven to be equally effective in both children and adults Randomisation in the control arm is important because it would be futile if the children in this arm would be treated with the same therapy by accident. Randomisation is necessary to make the trial as small and effective as possible. At this moment physicians do not have the tools to determine which therapy is the best for every child. This is why the investigators think it is correct to randomise in the control arm.
- Conditions
- Asthma in Children
- Being tested
- ADRB2-genotype guided treatment, Randomisation
- Keywords
- long-acting beta2-agonist, pharmacogenetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRB2-genotype guided treatmentGenetic
This intervention assesses whether ADRB2 genotype-guided treatment leads to better asthma control after 3 months compared to usual care in children who are uncontrolled despite adherent and adequate use of ICS.
RandomisationOther
In the control arm, children will be randomised over double dose ICS or ICS+LABA instead of treatment according to their genotype.
| Study group | Role | What they receive |
|---|---|---|
| ADRB2-genotype guided treatment arm | Active comparator | In the genotype-stratified arm, children will be treated based on their ADRB2 genotype. Children homozygous for the risk variant Arg16 and heterozygotes (Arg16Gly) will be treated with doubling dosages of their ICS. Children homozygous for the wild type allele (Gly16Gly) will receive LABA. Receives: Genetic: ADRB2-genotype guided treatment |
| Control arm | Active comparator | In the control arm, genotyping will be performed for retrospective analysis, but the genotype information will not be used to guide treatment. Children in this study arm will proceed randomisation between doubling ICS dosage (n=75) or LABA treatment (n=75), the two most commonly preferred add-on options among paediatric pulmonologists in the Netherlands. The investigators choose to randomize between both treatments options, since international guidelines do not agree on the preferred treatment option. Receives: Other: Randomisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control based on (childhood-)Asthma Control Test scores in the first 3 months of the trial
Patients will fill in the (childhood-)Asthma Control Test at baseline, after 3 months [Range score: 0 - 27, 20 or more means asthma under control]
Measured: 3 months
Secondary outcomes (12)
Change in asthma control at t=6 months (childhood-)Asthma Control Test
Patients will fill in the (childhood-)Asthma Control Test at baseline after 6 months [Range score: 0 - 27, 20 or more means asthma under control]
Measured: 6 months
Change in asthma-related school absences
Patients will fill in a questionnaire about asthma-related school absences [Minimum score 0 days, maximum score more than 10 days]
Measured: 6 months
Change in therapy in t = 3 months
Patients will be questioned what kind of treatment they use at baseline visit, after three months
Measured: 3 months
Time to reach asthma control (Asthma Control Test score ≥20)
Patients will fill in the (childhood-)Asthma Control Test at baseline, every month [Range score: 0 - 27, 20 or more means asthma under control]
Measured: 6 months
Cost-effectiveness of ADRB2 genotype guided treatment measured by the Productivity Cost Questionnaire
Patients will fill in the Productivity Cost Questionnaire at 0, 3 and 6 months. The IPCQ measures:
- absenteeism (number of days missed from work in the 4 weeks due to illness) -- minimum is 0, maximum (in theory) is 28 days
- Presenteeism (productivity lost while at work due to illness) -- minimum is 0, maximum is 224 hours.
In absenteeism, a lower number of days missed from work represent a better outcome; In presenteeism, a lower number of hours represent a better outcome For presenteeism the number of hours productivity loss is calculated by the following formula using data from the questionnaire.
presenteeism = number of workdays affected by illness * (1-efficiencyscore/10)*working hours per workday.
This results in a monetary value for productivity loss.
Measured: 3 and 6 months
In-depth integrative -omics analysis
Non-response to ICS treatment will be measured by analysing feces samples (microbiome) and nose swabs (epigenome). Nose swabs will be collected after 0, 3 and 6 months and feces after 1 month
Measured: 0, 3 and 6 months
Change in quality of life assessed by the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score
Measured by the Pediatric Asthma-related Quality of Life Questionnaire (PAQLQ). Children are asked to think about how they have been during the previous week and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all -
1 = extremely bothered). The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. Subscales are summed.
Measured: 0, 3 and 6 months
Change in fatigue scores assessed by the PedsQL questionnaire
Measured by the PedsQL questionnaire, a 23 item generic score scale consisting of physiological functioning, emotional functioning, social functioning and school functioning questions with multidimensional scales. Subscales are summed. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored.
Measured: 0, 3 and 6 months
change in FEV1 at t = 3 months
FEV1 will be measured at 0 and 3 months, change in FEV1 will be calculated.
Measured: 0 and 3 months
change in FEV1 at t = 6 months
FEV1 will be measured at t=0 and 6 months, change in FEV1 will be calculated
Measured: 0, 3 and 6 months
change in fraction of exhaled nitric oxide at t=3 months
Exhaled nitric oxide measures will be performed using the Niox Vero at t=0 and 3 months
Measured: 0 and 3 months
change in fraction of exhaled nitric oxide at t=6 months
Exhaled nitric oxide measures will be performed using the Niox Vero at t=0. 3 and 6 months
Measured: 0,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start12 Jun 2018
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, double-blind, precision medicine, randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Lung Foundation
- Responsible party
- Principal investigator, Prof. dr. A.H. Maitland-van der Zee, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Anke-Hilse Maitland-van der Zee, Prof. Dr., Principal investigator, Academic Medical Center, Department of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654508
- Sponsor's protocol ID
- NL63849.018.17
- Acronym
- PUFFIN
- Status last verified
- Nov 2023
- First submitted
- 14 May 2018
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics Use For Further Treatment Improvement in childreN
- ClinicalTrials.gov ID
- NCT03654508
- Acronym / sponsor ID
- PUFFIN / NL63849.018.17
- Conditions
- Asthma in Children
- Keywords
- long-acting beta2-agonist, pharmacogenetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Lung Foundation
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 31 Aug 2018 (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.
There is large heterogeneity in treatment response to asthma medication and a one-size fits all approach based on current guidelines might not fit all children with asthma. It is expected that children with one or more variant alleles (Arg16Arg and Arg16Gly) within the beta2 adrenergic receptor (ADRB2) gene coding for the beta2-receptor have a higher risk to poorly respond to long-acting beta2-agonists (LABA) comparing to the Gly16Gly wildtype.
Aims To study whether ADRB2 genotype-guided treatment will lead to improvement in asthma control in children with uncontrolled asthma on inhaled corticosteroids compared with usual care.
Design A multicentre, double-blind, precision medicine, randomized trial will be carried out within 20 Dutch hospitals. 310 asthmatic children (6-17 years of age) not well controlled on a low dose of inhaled corticosteroids (ICS) will be included and randomized over a genotype-guided and a non-genotype-guided(control) arm. In the genotype-guided arm children with Arg16Arg and Arg16Gly will be treated with double dosages of ICS and with the Gly16Gly wildtype with add on LABA. In the control arm children will be randomized over both treatment options. Lung function measurements, questionnaires focussing on asthma control (ACT/c-ACT) and quality of life, will be obtained in three visits within 6 months. The primary outcome will be improvement in asthma control based on repeated measurement analysis of c-ACT or ACT scores in the first three months of the trial. Additional cost effectiveness studies will be performed.
Conclusion Currently, pharmacogenetics is not used in paediatric asthmas. This trial may pave the way to implement promising results for genotype-guided treatment in paediatric asthma in clinical practice.
Detailed description
Study design: national, multi-centre, double-blind randomized controlled trial
Duration: 6 months, with 3 visits in the hospitals (at t=0, t=3 months and t=6 months)
Setting: Patients are recruited at out-patient asthma clinics in secondary and tertiary care hospitals in the Netherlands.
Description: Three hundred ten children (6 to 17 years of age) with a doctor's diagnosis of asthma and uncontrolled asthma symptoms despite adherent and adequate use of ICS for at least three months (step 2 asthma treatment) will be recruited by secondary and tertiary care centers in the Netherlands. All participants are eligible for step-up asthma treatment (from step 2 to step 3) as assessed by the treating paediatrician/paediatric pulmonologist. Participants will be randomized to a genotype-guided treatment arm (n=155) or to a usual care, non-genotype guided arm (n=155) and followed for 6 months.
Genotyping before start treatment During the baseline visit in the hospital, clinical data and biological samples (including a DNA sample) will be collected. Upon this visit, the DNA sample will be send to the Clinical Chemistry department of the Erasmus MC (Head: Prof. R. van Schaik) to perform genotyping of the ADRB2 gene within one week. The treating physician will adapt the treatment regime of the participant based on the treatment advice of the study coordinator (Table 1). For the children in the genotype-arm, this will be based on the genotype. The treating physician will not know (be blinded) whether the treatment advice was based on the genotype (intervention arm) or based on randomization (control arm). The participant will be followed for 6 months. If the participant is still uncontrolled at t=3 months, treatment will be adapted. All children will be genotyped, in order to assess the influence of the genotype on treatment outcome in the usual arm group retrospectively. The children should use the same inhalation device during the study to avoid confusion on how they should inhale their medication.
Furthermore, to test the hypothesis it is necessary to include enough children in the control group with Arg16Arg or Arg16Gly to be treated with LABA. The amount of children treated with LABA and ICS should be equal in the control group. Therefore children are randomized in the control group over doubling ICS (n=77) and adding LABA (n=77). This will lead to an estimated number of children with Arg16Arg or Arg16Gly of 51 who will get LABA add on. In this way the power is high enough to determine the effectivity of both treatment options in the three genotypes. The investigators find it important to define effectivity next to the question whether genotyping benefits children with asthma. In the control group DNA samples will be obtained for retrospective analysis.
It is safe to randomise the children again who are randomised within the control arm, because treatment with a double dose of ICS and adding a LABA are both standard of care. A Cochrane review from 2009 has shown that both treatments have proven to be equally effective in both children and adults Randomisation in the control arm is important because it would be futile if the children in this arm would be treated with the same therapy by accident. Randomisation is necessary to make the trial as small and effective as possible. At this moment physicians do not have the tools to determine which therapy is the best for every child. This is why the investigators think it is correct to randomise in the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- multicentre, double-blind, precision medicine, randomized trial
| Arm | Type | Receives |
|---|---|---|
| ADRB2-genotype guided treatment arm | Active comparator | Genetic: ADRB2-genotype guided treatmentIn the genotype-stratified arm, children will be treated based on their ADRB2 genotype. Children homozygous for the risk variant Arg16 and heterozygotes (Arg16Gly) will be treated with doubling dosages of their ICS. Children homozygous for the wild type allele (Gly16Gly) will receive LABA. |
| Control arm | Active comparator | Other: RandomisationIn the control arm, genotyping will be performed for retrospective analysis, but the genotype information will not be used to guide treatment. Children in this study arm will proceed randomisation between doubling ICS dosage (n=75) or LABA treatment (n=75), the two most commonly preferred add-on options among paediatric pulmonologists in the Netherlands. The investigators choose to randomize between both treatments options, since international guidelines do not agree on the preferred treatment option. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Doctor's diagnosis of asthma (ever) based on patient history, FEV1 reversibility ≥ 12% and/or bronchial hyperresponsiveness
- Current asthma symptoms (based on ACT (≥12 years) or C-ACT (<12 years) score ≤ 19
- ICS use ≥ 3 months before inclusion (start dosage ICS, treatment step 2 according to childhood asthma guideline NVK, Table 3)
- Adequate inhalation technique (based on validated checklist score [21])
- Self-assessed good adherence to maintenance asthma treatment
Key exclusion criteria (6 listed)
- Active smoking
- Congenital heart disease
- Serious lung disease other than asthma (Cystic Fibrosis, Primary Ciliary Dyskinesia, congenital lung disorders, severe immune disorders)
- LABA use in past 6 months
- Omalizumab use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADRB2-genotype guided treatmentThis intervention assesses whether ADRB2 genotype-guided treatment leads to better asthma control after 3 months compared to usual care in children who are uncontrolled despite adherent and adequate use of ICS. | Genetic | ADRB2-genotype guided treatment arm |
| RandomisationIn the control arm, children will be randomised over double dose ICS or ICS+LABA instead of treatment according to their genotype. | Other | Control arm |
Primary outcome
Asthma control based on (childhood-)Asthma Control Test scores in the first 3 months of the trial
Time frame: 3 months
Patients will fill in the (childhood-)Asthma Control Test at baseline, after 3 months [Range score: 0 - 27, 20 or more means asthma under control]
12 secondary outcomes
Change in asthma control at t=6 months (childhood-)Asthma Control Test
Time frame: 6 months
Change in asthma-related school absences
Time frame: 6 months
Change in therapy in t = 3 months
Time frame: 3 months
Time to reach asthma control (Asthma Control Test score ≥20)
Time frame: 6 months
Cost-effectiveness of ADRB2 genotype guided treatment measured by the Productivity Cost Questionnaire
Time frame: 3 and 6 months
In-depth integrative -omics analysis
Time frame: 0, 3 and 6 months
Change in quality of life assessed by the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score
Time frame: 0, 3 and 6 months
Change in fatigue scores assessed by the PedsQL questionnaire
Time frame: 0, 3 and 6 months
change in FEV1 at t = 3 months
Time frame: 0 and 3 months
change in FEV1 at t = 6 months
Time frame: 0, 3 and 6 months
change in fraction of exhaled nitric oxide at t=3 months
Time frame: 0 and 3 months
change in fraction of exhaled nitric oxide at t=6 months
Time frame: 0,3 and 6 months
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 7 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Anke-Hilse Maitland-van der Zee, Prof. Dr. principal investigator
Academic Medical Center, Department of Respiratory Medicine
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADRB2-genotype guided treatment and Randomisation in people with Asthma in Children, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 21 sites in 3 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 7 inclusion and 6 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Netherlands, Belgium, Switzerland. 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?
Asthma control based on (childhood-)Asthma Control Test scores in the first 3 months of the trial (time frame: 3 months). 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 7 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.