Long-term Effect of Dupilumab in N-ERD

Medical University of Vienna

Status

Not yet enrolling

Conditions

Nasal Polyposis

Chronic Rhinosinusitis (CRS)

NSAID-Induced Asthma

NSAIDs Hypersensitivity

Asthma Bronchiale

Treatments

Other: Observational follow-up of standard Dupilumab treatment

Study type

Observational

Funder types

Other

Identifiers

NCT07049978

DUPI-NERD-02

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.