Asthma
Conditions
Interventions
None listed
Sponsors
Franciscus Gasthuis & Vlietland
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients between 12 and 70 years old, diagnosed with asthma according to the GINA guidelines. If patients are doctor*s diagnosed with asthma based on clinical data, the further diagnostics will be performed to confirm the diagnosis after the AAE. - Mild to severe asthma, treated according to GINA guidelines with medium - or high dose inhaled corticosteroids (with or without LABA) or treated with a low dose inhaled corticosteroids combined LABA or leukotriene - receptor antagonist. - Asthma exacerbation, indication for systemic corticosteroids. - Written personal and/or parental informed consent, prior to any study procedures. - Eligibility and willingness to present during an asthma exacerbation at the outpatient clinic of the Study sites. - Ability to use e - health applications.
Exclusion criteria
Exclusion criteria: - Immunosuppressive maintenance medication (azithromycin, systemic corticosteroids maintenance therapy and other) or recently (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the relation of phenotypical characteristics with treatment response at day 7, defined by 1) the physician - and patient rated global evaluation of treatment effectiveness (GETE) score 2) difference in Asthma Control Questionnaire 5 (ACQ-5) (> 0.5) 3) difference in handheld spirometry values like forced expiratory volume (FEV1 >= 10%). Treatment response will be classified as excellent, good, moderate or poor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are 1) a prediction model for the treatment response of AAE 2) aetiology of the AAEs 3) blood and local respiratory parameters; microbiota composition; lipid metabolomics and volatile compounds composition at baseline and AAE | — |
Countries
Netherlands
Outcome results
None listed