Status:
UNKNOWN
Effect of Dupilumab on Aspirin Intolerance
Lead Sponsor:
Medical University of Vienna
Conditions:
AERD - Aspirin Exacerbated Respiratory Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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...
Detailed Description
30 patients suffering from AERD will be included in this single-center, prospective, explorative study for treatment with dupilumab. Before study initiation, informed consent will be obtained from all...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04442256
Start Date
June 1 2020
End Date
December 31 2022
Last Update
April 6 2022
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090