Effect of Dupilumab on Aspirin Intolerance

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To test the efficacy of dupilumab in patients with AERD regarding the intolerance to salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of dupilumab treatment.

Hypothesis:

After 6 months of therapy, patients will tolerate aspirin dose levels as tested with different dosages (125mg, 250mg and 500 mg).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Aspirin

Criteria

Inclusion Criteria:

Dupilumab treatment group:

• Signed and dated informed consent has been obtained

• Age 18 - 70 years

• Male or female

• Diagnosed with AERD (nasal polyps, allergic asthma, aspirin intolerance)

• Chronic rhinosinusitis with nasal polyps (CRSwNP) (according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines)8

• Documented aspirin intolerance

• Asthma bronchial diagnosed by a respiratory physician (based on Global -Initiative for Asthma guidelines)9

Exclusion Criteria:

• Pregnancy

• 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