The analysis of molecular profiles in exhaled breath by an electonic nose (eNose) is able to: a. Discriminate between patients with severe asthma who respond to treatment with mepolizumab and those who do not respond to mepolizumab with at least…
ID
Bron
Verkorte titel
Aandoening
Severe Asthma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- eNose ‘Breathprints’ (signature of mixtures of volatile organic compounds (VOCs) in exhaled breath)
Achtergrond van het onderzoek
-
Doel van het onderzoek
The analysis of molecular profiles in exhaled breath by an electonic nose (eNose) is able to:
a. Discriminate between patients with severe asthma who respond to treatment with mepolizumab and those who do not respond to mepolizumab with at least 85% accuracy.
b. Replicate the findings in a. with at least 80% accuracy in an external validation.
Onderzoeksopzet
Baseline, 6 months, 12 months
Onderzoeksproduct en/of interventie
Niet van toepassing
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patients with severe refractory eosinophilic asthma who are treated with Mepolizumab.
-Poor asthma control or frequent (≥2 per year) exacerbations, despite high-intensity treatment while alternative diagnoses have been excluded, comorbidities are treated and compliance has been checked.
-Peripheral blood eosinophil levels ≥150 cells/µl.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Alcohol use <12 hours prior to measurement.
- Unwillingness or inability to comply with the study protocol for any other reason.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7128 |
| NTR-old | NTR7474 |
| Ander register | METC AMC. The MEC of the AMC ruled that the Medical Research Involving Human Subjects Act (WMO) does not apply to the study and that an official approval of this study by the MEC is not required. : W14_112 # 14.17.0147 |