Effect of Dupilumab on Aspirin Intolerance

Sponsor
Medical University of Vienna
Study ID
NCT04442256
Phase
PHASE4
Status
Unknown

Conditions

  • AERD - Aspirin Exacerbated Respiratory Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Dupilumab — DRUG
    All patients will be administered subcutaneous doses of dupilumab in a biweekly fashion.

Study Details

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).

Key Dates

Start date
Jun 1, 2020
Status verified
Apr 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Dupilumab
    All patients will be administered subcutaneous doses of dupilumab in a monthly fashion. Observation period will be 30 minutes after injection

Primary Outcome Measure

Maximally tolerated aspirin dose level (stages 125mg, 250mg and 500mg) [ Time Frame: 6 months ]

Central Contacts