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)

Phase 4

Not yet recruiting

• Conditions: non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD)

• Registration Number: 2024-520082-31-01
• Lead Sponsor: Medical University Of Vienna

Brief Summary

The main goal of this study is to assess the long-term effect of Dupilumab on patients with N-ERD with a special focus on the long-term effects of Dupilumab on salicylic acid tolerance. We hope to find higher rates of salicylic acid tolerant patients compared to before treatment and 6 months after treatment initiation.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Participated previously in a previous study (EK 1044/2020) 2. Signed and dated informed consent has been obtained 3. Current therapy with Dupilumab

Exclusion Criteria

1. Pregnancy (as determined by urine ß-HCG test) 2. Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C) 3. History of malignancy or immunodeficiency 4. Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis) 5. Need for systemic corticosteroid therapy 1 month prior to screening visit 6. Eosinophilic pneumonia and Churg-Strauss Syndrome

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerated aspirin dose levels as tested with different dosages (62.5mg, 125mg, 250mg and 500 mg) compared to tolerated dosages before and 6 months into Dupilumab treatment.		Tolerated aspirin dose levels as tested with different dosages (62.5mg, 125mg, 250mg and 500 mg) compared to tolerated dosages before and 6 months into Dupilumab treatment.

Secondary Outcome Measures

Name	Time	Method
1. Serum ECP, total IgE, allergen specific IgE, tryptase, peripheral blood eosinophils 2. Allergenic sensitization as assessed by skin prick and blood test 3. Olfactory performance 4. Prostaglandin levels in urine 5. Cytokine pattern in nasal secretions 6. Inflammatory cytokine patterns at mRNA levels 7. Nasal microbiome composition 8. TPS, VAS, SNOT-22 9. ACT, ACQ		1. Serum ECP, total IgE, allergen specific IgE, tryptase, peripheral blood eosinophils 2. Allergenic sensitization as assessed by skin prick and blood test 3. Olfactory performance 4. Prostaglandin levels in urine 5. Cytokine pattern in nasal secretions 6. Inflammatory cytokine patterns at mRNA levels 7. Nasal microbiome composition 8. TPS, VAS, SNOT-22 9. ACT, ACQ

Trial Locations

Locations (1)

Medical University Of Vienna; 🇦🇹 Vienna, Austria

Medical University Of Vienna

🇦🇹Vienna, Austria

Sven Schneider

Site contact

+4314040034380

Sven.schneider@meduniwien.ac.at