An observational study in Severe Asthma, sponsored by Franciscus Gasthuis. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Franciscus Gasthuis · Observational
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
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 61 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Franciscus Gasthuis is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult severe asthma patients that will start tezepelumab therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Tapering of inhaled corticosteroid (ICS) treatment
All patients that have started tezepelumab treatment are eligible for tapering of ICS, since it is part of standard care.
Total inhalation corticosteroid burden
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
Time frame: From enrollment to the end of follow-up at 12 months
Total corticosteroid use (including oral corticosteroids)
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
Time frame: From enrollment to the end of follow-up at 12 months
Various metabolic outcome measures
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
Time frame: From enrollment to the end of follow-up at 12 months
Annualized Rate of Asthma Exacerbations
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
Time frame: From enrollment to the end of follow-up at 12 months
Blood pressure (in mm Hg)
Blood pressure (in mm Hg)
Time frame: From enrollment to the end of follow-up at 12 month
weight (kg)
weight (kg)
Time frame: From enrollment to the end of follow-up at 12 months
BMI (in kg/m2)
BMI (in kg/m2)
Time frame: From enrollment to the end of follow-up at 12 months
abdominal circumference ( in cm)
abdominal circumference ( in cm)
Time frame: From enrollment to the end of follow-up at 12 months
ALAT (in IU/ml)
ALAT (in IU/ml)
Time frame: From enrollment to the end of follow-up at 12 months
ASAT (in IU/ml)
ASAT (in IU/ml)
Time frame: From enrollment to the end of follow-up at 12 months
thrombocytes (amount of cellsx10^9/L)
thrombocytes (amount of cellsx10\^9/L)
Time frame: From enrollment to the end of follow-up at 12 months
leukocyte differentiation(amount of cells x10^9/L)
leukocyte differentiation(amount of cells x10\^9/L)
Time frame: From enrollment to the end of follow-up at 12 months
FIB4-score
Noninvasive estimate of liver scarring. Measured as a score and is a composite of age, ALAT, ASAT and platelet count
Time frame: From enrollment to the end of follow-up at 12 months
LDL-C (in mmol/L)
LDL-C (in mmol/L)
Time frame: From enrollment to the end of follow-up at 12 months
HDL-C (in mmol/L)
HDL-C (in mmol/L)
Time frame: From enrollment to the end of follow-up at 12 months
triglycerides (in mmol/L)
triglycerides (in mmol/L)
Time frame: From enrollment to the end of follow-up at 12 months
apoB (in g/L)
apoB (in g/L)
Time frame: From enrollment to the end of follow-up at 12 months
HbA1c (in mmol/mol)
HbA1c (in mmol/mol)
Time frame: From enrollment to the end of follow-up at 12 months
Plan to share: No
No publications or documents are linked to this record.
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Franciscus Gasthuis