Severe Asthma
Conditions
Keywords
Tapering, ICS, Tezepelumab, Metabolic effects, Exacerbations, Asthma, Biologics
Brief summary
To evaluate the relationship between starting tezepelumab treatment followed by tapering of inhaled corticosteroid (ICS) and ICS dose, metabolic outcomes, asthma control and exacerbation rate in a real world setting
Interventions
All patients that have started tezepelumab treatment are eligible for tapering of ICS, since it is part of standard care.
Sponsors
Franciscus Gasthuis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Patient diagnosed with severe asthma according to the GINA guidelines * Written informed consent (AVG). * Eligibility and willingness to present during an asthma exacerbation at the Franciscus hospital. * Patient has received/or has been planned for at least one dose of tezepelumab * Sufficient understanding of the Dutch or English language
Exclusion criteria
* Other underlying inflammatory or auto-immune diseases that require OCS treatment, such as rheumatologic disease, IBD etc. * Pregnancy, because of the possible altered immunological status. * Participation in an interventional study that interferes with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total inhalation corticosteroid burden | From enrollment to the end of follow-up at 12 months | Data on ICS use will be collected at baseline (before tezepelumab initiation) and 12 months post initiation. Total daily dose will be measured as mcg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total corticosteroid use (including oral corticosteroids) | From enrollment to the end of follow-up at 12 months | Data on corticosteroid use (ICS dose and OCS courses) will be collected at baseline (before tezepelumab initiation) and 12 months post initiation. Total daily dose will be measured as mcg/day |
| Various metabolic outcome measures | From enrollment to the end of follow-up at 12 months | Various metabolic outcome measures mentioned under "other pre-specified outcomes measures" will be assessed as part of the secondary outcome measure: metabolic outcomes Blood pressure (in mm Hg), weight (kg) , BMI (in kg/m2), abdominal circumference ( in cm), lipid spectrum (in mmol/L), ALAT (in IU/ml), ASAT (in IU/ml), thrombocytes (amount of cellsx10\^9/L), leukocyte differentiation(amount of cells x10\^9/L), FIB4, LDL-C (in mmol/L), HDL-C (in mmol/L), triglycerides (in mmol/L), apoB (in g/L) and HbA1c (in mmol/mol) will be assessed at baseline and at 12 months |
| Annualized Rate of Asthma Exacerbations | From enrollment to the end of follow-up at 12 months | Asthma exacerbations will be captured for two periods i.e. the year preceding V=0 and the year after V=0 until T=12 months |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORGert-Jan Braunstahl, Dr.
Franciscus Gasthuis & Vlietland
Outcome results
None listed