Asthma exacerbation Asthma attack
Conditions
Interventions
None listed
Sponsors
Franciscus
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (16+) patient diagnosed with asthma according to the GINA guidelines.Severe asthma treated with biologicals (tezepelumab, omalizumab, benralizumab, mepolizumab, reslizumab of dupilumab), for at least 3 months prior to inclusion.Asthma exacerbation with indication for systemic corticosteroids.Written personal informed consent, prior to any study procedures.Eligibility and willingness to present during an asthma exacerbation at the outpatient clinic facility of the study sites.
Exclusion criteria
Exclusion criteria: Immunosuppressive maintenance medication (azithromycin, systemic corticosteroids maintenance therapy and other) or recently (<6 weeks) discontinued these medications. (desensitization therapy indicated for allergies can be included in the study).Other underlying active inflammatory or auto-immune diseases, such as rheumatologic disease, for which immunosuppressive medication is used at the moment of inclusion.Involvement in the planning and/or conduct of the study.Pregnancy, because of the possible altered immunological status.Participation in an interventional study or randomised controlled trial.Already started with corticosteroids course before possible inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the baseline exacerbation characteristics and the treatment response based on Global Evaluation of Treatment Effect (GETE) on day 7, ?ACQ-5 (between day 0 and day 7) and ?FEV1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are to compare the baseline exacerbation characteristics and chance on relapse within 6 weeks after initial AE treatment with patients without biological treatment, and to compare the change in spirometry en oscillometry within the first week after initiation of exacerbation treatment. | — |
Countries
Netherlands
Contacts
Public ContactS Deelen
Franciscus
Outcome results
None listed