Long-term Effect of Dupilumab in N-ERD

NCT ID: NCT07049978

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

N-ERD patients with long-term Dupilumab treatment

Patients diagnosed with N-ERD undergoing Dupilumab treatment between 3 and 4 years

Observational follow-up of standard Dupilumab treatment

Intervention Type: OTHER

Patients undergoing Dupilumab treatment for N-ERD will be observed after three to four years of treatment to assess long term 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.

Interventions

Observational follow-up of standard Dupilumab treatment

Patients undergoing Dupilumab treatment for N-ERD will be observed after three to four years of treatment to assess long term 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Sven Schneider, MD

Priv.-Doz. DDr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sven Schneider Dr. med. univ., MD

Role: PRINCIPAL_INVESTIGATOR

Senior doctor and Department of Otorhinolaryngology at Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Central Contacts

Karina Bayer Dr. med. univ., MD

Role: CONTACT

karina.bayer@meduniwien.ac.at

014040033480

Facility Contacts

Karina Bayer Dr. med. univ., MD

Role: primary

karina.bayer@meduniwien.ac.at

014040033480

Julia Eckl-Dorna MD, PhD, MD, PhD

Role: backup

julia.eckl-dorna@meduniwien.ac.at

+43 1 40400-34380

References

Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar.

Reference Type: BACKGROUND

PMID: 36549708 (View on PubMed)

Other Identifiers

DUPI-NERD-02

Identifier Type: -

Identifier Source: org_study_id