Long-term Effect of Dupilumab in N-ERD

Not yet recruiting

• Conditions: Asthma Bronchiale; Nasal Polyposis; Chronic Rhinosinusitis (CRS); NSAID-Induced Asthma; NSAIDs Hypersensitivity

• Registration Number: NCT07049978
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-25
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ASA tolerance	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 Outcome Measures

Name	Time	Method
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)	Sinonasal symptoms assessed with SNOT-22 questionnaire at long-term follow-up, higher score means higher limitation by disease.
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)	General quality of life at long-term follow-up, higher score means good QoL.
Change in Asthma Control Questionnaire (ACQ-5) score	Historical baseline and 6-month vs. current score (≥3 years post-treatment)	Asthma control evaluated via ACQ-5, high score means high disease burden.
Change in peripheral eosinophil count	Historical baseline and 6-month vs. current score (≥3 years post-treatment)	Long-term effect of Dupilumab on peripheral eosinophils
Nasal microbiome composition at long-term follow-up	Historical baseline and 6-month vs. current score (≥3 years post-treatment)	Microbial composition from nasal swabs assessed via sequencing

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria