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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)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520082-31-01
Enrollment
30
Registered
2025-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Detailed description

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

Interventions

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026