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Enrolling by Invitation

NCT Number: NCT07713498

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

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

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tapering of inhaled corticosteroid (ICS) treatment

Other

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

Primary outcomes

  1. Total inhalation corticosteroid burden

    Time frame: 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 outcomes

  1. Total corticosteroid use (including oral corticosteroids)

    Time frame: 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

  2. Various metabolic outcome measures

    Time frame: 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

  3. Annualized Rate of Asthma Exacerbations

    Time frame: 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

Other outcomes

  1. Blood pressure (in mm Hg)

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

    Blood pressure (in mm Hg)

  2. weight (kg)

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

    weight (kg)

  3. BMI (in kg/m2)

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

    BMI (in kg/m2)

  4. abdominal circumference ( in cm)

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

    abdominal circumference ( in cm)

  5. ALAT (in IU/ml)

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

    ALAT (in IU/ml)

  6. ASAT (in IU/ml)

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

    ASAT (in IU/ml)

  7. thrombocytes (amount of cellsx10^9/L)

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

    thrombocytes (amount of cellsx10^9/L)

  8. leukocyte differentiation(amount of cells x10^9/L)

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

    leukocyte differentiation(amount of cells x10^9/L)

  9. FIB4-score

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

    Noninvasive estimate of liver scarring. Measured as a score and is a composite of age, ALAT, ASAT and platelet count

  10. LDL-C (in mmol/L)

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

    LDL-C (in mmol/L)

  11. HDL-C (in mmol/L)

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

    HDL-C (in mmol/L)

  12. triglycerides (in mmol/L)

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

    triglycerides (in mmol/L)

  13. apoB (in g/L)

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

    apoB (in g/L)

  14. HbA1c (in mmol/mol)

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

    HbA1c (in mmol/mol)

Sponsors and collaborators

Lead sponsor

Franciscus Gasthuis

Other

Registry information

Official study title

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

Acronym: TITANIC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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