ClinicalTrials.gg
Enrolling by invitationNCT07713498TITANICUpdated Jul 21, 2026

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Severe Asthma

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Keywords

  • Tapering
  • ICS
  • Tezepelumab
  • Metabolic effects
  • Exacerbations
  • Asthma
  • Biologics
03

In context

Asthma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • Age ≥18
  • Patient diagnosed with severe asthma according to the GINA guidelines
  • Written (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

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.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (estimated)
Patient registry
No

Groups and cohorts

  • Severe asthma patient that have started tezepelumab treatment

    Other: Tapering of inhaled corticosteroid (ICS) treatment

Interventions

  • OtherTapering 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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Other outcomes

  1. Blood pressure (in mm Hg)

    Blood pressure (in mm Hg)

    Time frame: From enrollment to the end of follow-up at 12 month

  2. weight (kg)

    weight (kg)

    Time frame: From enrollment to the end of follow-up at 12 months

  3. BMI (in kg/m2)

    BMI (in kg/m2)

    Time frame: From enrollment to the end of follow-up at 12 months

  4. abdominal circumference ( in cm)

    abdominal circumference ( in cm)

    Time frame: From enrollment to the end of follow-up at 12 months

  5. ALAT (in IU/ml)

    ALAT (in IU/ml)

    Time frame: From enrollment to the end of follow-up at 12 months

  6. ASAT (in IU/ml)

    ASAT (in IU/ml)

    Time frame: From enrollment to the end of follow-up at 12 months

  7. 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

  8. 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

  9. 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

  10. LDL-C (in mmol/L)

    LDL-C (in mmol/L)

    Time frame: From enrollment to the end of follow-up at 12 months

  11. HDL-C (in mmol/L)

    HDL-C (in mmol/L)

    Time frame: From enrollment to the end of follow-up at 12 months

  12. triglycerides (in mmol/L)

    triglycerides (in mmol/L)

    Time frame: From enrollment to the end of follow-up at 12 months

  13. apoB (in g/L)

    apoB (in g/L)

    Time frame: From enrollment to the end of follow-up at 12 months

  14. HbA1c (in mmol/mol)

    HbA1c (in mmol/mol)

    Time frame: From enrollment to the end of follow-up at 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07713498
Lead sponsor
Franciscus Gasthuis
Responsible party
Gert-Jan Braunstahl (Pulmonologist, Franciscus Gasthuis) — Principal investigator
First posted
Jul 20, 2026
Start date
May 1, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Gert-Jan Braunstahl, Dr.
principal investigator · Franciscus Gasthuis & Vlietland

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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