Long-term Effect of Dupilumab in N-ERD

Official title

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)

Overview

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.

Interventions

• Other 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.

Primary outcome measures

• Change in ASA tolerance [Time frame: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)]

Secondary outcome measures (5)

• Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response [Time frame: 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 [Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]
• Change in Asthma Control Questionnaire (ACQ-5) score [Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]
• Change in peripheral eosinophil count [Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]
• Nasal microbiome composition at long-term follow-up [Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Austria · 1 center

• Medical University of Vienna — Vienna

Publications

• 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

Identifiers

NCT: NCT07049978 · DUPI-NERD-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗