Long-term Effect of Dupilumab in N-ERD

N/ANot Yet RecruitingNCT07049978

Medical University of Vienna30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Observational follow-up of standard Dupilumab treatmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of Vienna

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

Change in ASA tolerance

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

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

Secondary Outcomes

Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response

Sinonasal symptoms assessed with SNOT-22 questionnaire at long-term follow-up, higher score means higher limitation by disease.

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

General quality of life at long-term follow-up, higher score means good QoL.

Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)

Change in Asthma Control Questionnaire (ACQ-5) score

Asthma control evaluated via ACQ-5, high score means high disease burden.

Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)

Change in peripheral eosinophil count

Long-term effect of Dupilumab on peripheral eosinophils

Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)

Nasal microbiome composition at long-term follow-up

Microbial composition from nasal swabs assessed via sequencing

Time frame: Historical baseline and 6-month vs. current score (≥3 years post-treatment)

Central Contacts

Karina Bayer Dr. med. univ., MD

CONTACT

014040033480 karina.bayer@meduniwien.ac.at

Data from ClinicalTrials.gov

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