Dupilumab for Aspirin-exacerbated Respiratory Disease

• Status: Completed
• Trial end date: 2019-12-11
• Target enrollment: 0
• Participant gender: All

Summary

Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rochester General Hospital
• Treatments: Antibodies, Monoclonal; Aspirin

Criteria

Inclusion Criteria:

1. Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity

2. All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.

3. Able to understand and willingness to sign informed consent

4. Able to comply with study procedures

Exclusion Criteria:

1. Patient < 18 years of age

2. Pregnancy or breast feeding

3. Current tobacco use

4. Significant, uncontrolled medical conditions

5. Ongoing malignancy or history of malignancy in remission within the past 12 months

6. Current treatment with immunosuppressive medications except chronic oral steroids

7. Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)

8. Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment