Genotype-guided treatment of children with uncontrolled asthma

Pharmacogenetics Use For Further treatment Improvement in childreN (PUFFIN) trial - PUFFIN

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004424-29-NL

Enrollment

Registered

2017-12-21

Start date

2018-03-23

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with persistent uncontrolled asthma

Interventions

Trade Name: Registered long-acting beta2 agonists (LABA): salmeterol (generic, Serevent), formoterol (generic, Atimos, Oxis), olodacterol (Striverdi). Pharmaceutical Form: Inhalation s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Between 6-18 years of age - Doctor's diagnosis of asthma (ever) based on patient history, FEV1 reversibility >= 12% ever and/or bronchial hyperresponsiveness ever. - Current asthma symptoms (based on ACT (>= 12 years) or c-ACT (= 3 months before inclusion (start dosage ICS treatment step 2 according to childhood asthma guideline (NVK)) - adequate inhalation technique - self-assessed good adherence to maintenance asthma treatment - understanding of Dutch Language - internet access at home, willing to fill in questionnaires Are the trial subjects under 18? yes Number of subjects for this age range: 310 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - active smoking - congenital heart disease - serious lung disease other than asthma - LABA use in the past 6 months - omalizumab use - ICU admission in the previous year

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether ADRB2-genotype guided asthma treatment in children with persistent asthma symptoms despite ICS treatment leads to better asthma control compared to non-genotype guided asthma treatment;Secondary Objective: Not applicable;Primary end point(s): Asthma control according to the Asthma Control Test (ACT) or childhood-Asthma Control Test (c-ACT);Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To assess whether ADRB2-genotype guided asthma treatment in children with persistent asthma symptoms despite ICS treatment leads to better asthma control compared to non-genotype guided asthma treatment;Secondary Objective: Not applicable;Primary end point(s): Asthma control according to the Asthma Control Test (ACT) or childhood-Asthma Control Test (c-ACT);Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): RNA expression Microbiome Lung Function FeNO cost-effectiveness ;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Netherlands

Contacts

Public ContactElise Slob

Academic Medical Center

e.m.slob@amc.nl00312056665995

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026