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

NCT07713498 | Enrolling By Invitation FDA Drug

• 1 other identifier: 2874
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Severe Asthma

Keywords

Tapering; ICS; Tezepelumab; Metabolic effects; Exacerbations; Asthma; Biologics

Outcome Measures

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

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

Secondary Outcomes (3)

• Total corticosteroid use (including oral corticosteroids)

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

• Various metabolic outcome measures

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

• Annualized Rate of Asthma Exacerbations

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

Other Outcomes (14)

• Blood pressure (in mm Hg)

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

• weight (kg)

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

• BMI (in kg/m2)

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

Study Arms (1)

Severe asthma patient that have started tezepelumab treatment

Other: Tapering of inhaled corticosteroid (ICS) treatment

Interventions

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.

Severe asthma patient that have started tezepelumab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult severe asthma patients that will start tezepelumab therapy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscus Gasthuis: lead

Study Sites (1)

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

Location

MeSH Terms

Conditions

Asthma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gert-Jan Braunstahl, Dr.

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: July 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)