Tapering of Inhaled Corticosteroids in Tezepelumab-treated Asthma patieNts: Impact on Clinical Outcomes

N/AEnrolling By InvitationNCT07713498

Franciscus Gasthuis61 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Severe Asthma

Interventions

Tapering of inhaled corticosteroid (ICS) treatmentOTHER

All patients that have started tezepelumab treatment are eligible for tapering of ICS, since it is part of standard care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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