Severe AsthmaTITANICNCT07713498
Tapering of Inhaled Corticosteroids in Tezepelumab-treated Asthma patieNts: Impact on Clinical Outcomes
An observational study of Severe Asthma, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Tapering of inhaled corticosteroid (ICS) treatment
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult severe asthma patients that will start tezepelumab therapy.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
About this study
Official title: TITANIC - 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
- Conditions
- Severe Asthma
- Being tested
- Tapering of inhaled corticosteroid (ICS) treatment
- Keywords
- Tapering, ICS, Tezepelumab, Metabolic effects, Exacerbations, Asthma, Biologics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Severe asthma patient that have started tezepelumab treatment | Not described Receives: Other: Tapering of inhaled corticosteroid (ICS) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of follow-up at 12 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gert-Jan Braunstahl, Franciscus Gasthuis
- Investigators
- Gert-Jan Braunstahl, Dr., Principal investigator, Franciscus Gasthuis & Vlietland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713498
- Sponsor's protocol ID
- 2874
- Acronym
- TITANIC
- Status last verified
- Jul 2026
- First submitted
- 1 May 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TITANIC - Tapering of Inhaled Corticosteroids in Tezepelumab-treated Asthma patieNts: Impact on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07713498
- Acronym / sponsor ID
- TITANIC / 2874
- Conditions
- Severe Asthma
- Keywords
- Tapering, ICS, Tezepelumab, Metabolic effects, Exacerbations, Asthma, Biologics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe asthma patient that have started tezepelumab treatment | – | Other: Tapering of inhaled corticosteroid (ICS) treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult severe asthma patients that will start tezepelumab therapy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapering of inhaled corticosteroid (ICS) treatmentAll patients that have started tezepelumab treatment are eligible for tapering of ICS, since it is part of standard care. | Other | Severe asthma patient that have started tezepelumab treatment |
Primary outcome
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
3 secondary outcomes
Total corticosteroid use (including oral corticosteroids)
Time frame: From enrollment to the end of follow-up at 12 months
Various metabolic outcome measures
Time frame: From enrollment to the end of follow-up at 12 months
Annualized Rate of Asthma Exacerbations
Time frame: From enrollment to the end of follow-up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gert-Jan Braunstahl, Dr. principal investigator
Franciscus Gasthuis & Vlietland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Franciscus Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total inhalation corticosteroid burden (time frame: From enrollment to the end of follow-up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.