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Clinical Trials/NCT07049978
NCT07049978Not yet recruitingNot Applicable

Long-term Effect of Dupilumab on Acetylsalicylic Acid (ASA) Intolerance and Its Mechanisms in Patients With Non-steroidal Anti-inflammatory Drug-exacerbated Respiratory Disease (N-ERD)

Medical University of Vienna1 site in 1 country30 target enrollmentStarted: July 1, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
Change in ASA tolerance
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This prospective observational study investigates the long-term effects of Dupilumab in patients with NSAID-exacerbated respiratory disease (N-ERD). The study assesses changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. All participants are receiving Dupilumab as part of standard clinical care.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participated previously in our preliminary study (EK 1044/2020) and continued Dupilumab treatment since then. Long-term use of Dupilumab since the preliminary study will be assessed based on patient self-report, as there is currently no clinical test or laboratory parameter available to objectively verify treatment duration.
  • •Signed and dated informed consent has been obtained
  • •Current therapy with Dupilumab

Exclusion Criteria

  • •Pregnancy (as determined by urine ß-HCG test)
  • •Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C)
  • •History of malignancy or immunodeficiency
  • •Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis)
  • •Need for systemic corticosteroid therapy 1 month prior to screening visit
  • •Eosinophilic pneumonia and Churg-Strauss Syndrome
  • •Previous anaphylaxis and contraindications against ASA as outlined in the official prescribing information.

Outcomes

Primary Outcomes

Change in ASA tolerance

Time Frame: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)

Change in aspirin tolerance assessed via oral provocation test with standardized protocol

Secondary Outcomes

  • Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response(Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment))
  • Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) score compared to early response(Historical baseline and 6-month vs. current score (≥3 years post-treatment))
  • Change in Asthma Control Questionnaire (ACQ-5) score(Historical baseline and 6-month vs. current score (≥3 years post-treatment))
  • Change in peripheral eosinophil count(Historical baseline and 6-month vs. current score (≥3 years post-treatment))
  • Nasal microbiome composition at long-term follow-up(Historical baseline and 6-month vs. current score (≥3 years post-treatment))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sven Schneider, MD

Priv.-Doz. DDr.

Medical University of Vienna

Study Sites (1)

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