Long-term Effect of Dupilumab in N-ERD

NCT07049978 | Not Yet Recruiting

• 1 other identifier: DUPI-NERD-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in ASA tolerance

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

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

Secondary Outcomes (5)

• 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)

Study Arms (1)

N-ERD patients with long-term Dupilumab treatment

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

Other: Observational follow-up of standard Dupilumab treatment

Interventions

Observational follow-up of standard Dupilumab treatment 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.

N-ERD patients with long-term Dupilumab 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

Adults with NSAID-exacerbated respiratory disease (NERD), previously included in a Dupilumab follow-up study, now being evaluated after ≥3 years of treatment.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 36549708 BACKGROUND

MeSH Terms

Conditions

Asthma, Aspirin-Induced; Nasal Polyps

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sven Schneider Dr. med. univ., MD

  Senior doctor and Department of Otorhinolaryngology at Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Bayer Dr. med. univ., MD

CONTACT

014040033480; karina.bayer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. DDr.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)