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NCT Number: NCT07049978

Long-term Effect of Dupilumab in N-ERD

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.

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Key information

Conditions

NSAID-Induced Asthma Asthma Asthma Bronchiale Asthma, Aspirin-Induced Bronchial Diseases Chemically-Induced Disorders Chronic Rhinosinusitis (CRS) Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hypersensitivity Hypersensitivity, Immediate Immune System Diseases NSAIDs Hypersensitivity Nasal Polyposis Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in ASA tolerance

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

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

Secondary outcomes

  1. 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)

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

  2. 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)

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

  3. Change in Asthma Control Questionnaire (ACQ-5) score

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

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

  4. Change in peripheral eosinophil count

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

    Long-term effect of Dupilumab on peripheral eosinophils

  5. Nasal microbiome composition at long-term follow-up

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

    Microbial composition from nasal swabs assessed via sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

Karina Bayer Dr. med. univ., MD

CONTACT

[email protected]

014040033480

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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