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Exhaled biomarker analysis for therapy stratification in asthma (STRATA)

Exhaled biomarker analysis for therapy stratification in asthma (STRATA) - STRATA

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43274
Enrollment
300
Registered
2016-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Asthma

Interventions

asthma
children
exhaled biomarkers
therapy stratification

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Asthma diagnosis: established clinician diagnosis of asthma according to GINA guidelines Treatment: patients receiving GINA step 3,4 or 5 treatment Age: *6 -

Exclusion criteria

Exclusion criteria: Established other pulmonary disease Recent IMP study within 5.5 half lives of the study drug to the date of last drug administration. Not being able to perform lung function measurements due to neurologic disease or developmental delay

Design outcomes

Primary

MeasureTime frame
Differences in exhaled biomarker profile, between children responding to treatment and children not responding to treatment.

Secondary

MeasureTime frame
Target biomarker concentrations of different breath fractions of the same patient will be compared and aggregated at a group level. Assessed parameters will include the reproducibility and the breath fraction that carries the highest chemical information content, highest level of target biomarkers and allows the shortest collection time. Taking these various factors into account an optimal sampling strategy will be selected. This strategy will be used to study the secondary and main study aim.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)