Exhaled biomarker analysis for therapy stratification in asthma (STRATA)
Withdrawn
- Conditions
- Asthma10038716
- Registration Number
- NL-OMON43274
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 300
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 - < 18 years
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Differences in exhaled biomarker profile, between children responding to<br /><br>treatment and children not responding to treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Target biomarker concentrations of different breath fractions of the same<br /><br>patient will be compared and aggregated at a group level. Assessed parameters<br /><br>will include the reproducibility and the breath fraction that carries the<br /><br>highest chemical information content, highest level of target biomarkers and<br /><br>allows the shortest collection time. Taking these various factors into account<br /><br>an optimal sampling strategy will be selected. This strategy will be used to<br /><br>study the secondary and main study aim. </p><br>