No registrations found.
ID
Source
Brief title
Health condition
Severe Asthma
Sponsors and support
Intervention
Outcome measures
Primary outcome
- eNose ‘Breathprints’ (signature of mixtures of volatile organic compounds (VOCs) in exhaled breath)
Secondary outcome
-Absence of exacerbations during 12 months after initiation of mepolizumab therapy.
-Improvement of Asthma Control Questionnaire (ACQ)-score by 0.5 points over 6 months.
-Decrease of oral corticosteroid (OCS) use by 50% after 12 months.
-Any switch of biological therapy.
Background summary
-
Study objective
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.
Study design
Baseline, 6 months, 12 months
Intervention
Niet van toepassing
Inclusion criteria
- 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.
Exclusion criteria
- Alcohol use <12 hours prior to measurement.
- Unwillingness or inability to comply with the study protocol for any other reason.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7128 |
| NTR-old | NTR7474 |
| Other | 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 |