Genotype-guided treatment of children with uncontrolled asthma

Phase 1

• Conditions: Children with persistent uncontrolled asthma; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2017-004424-29-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 25

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 (< 12 years) score <= 19
ICS use >= 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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> Secondary end point(s): RNA expression<br> Microbiome<br> Lung Function<br> FeNO<br> cost-effectiveness<br> ;Timepoint(s) of evaluation of this end point: 6 months