Dupilumab for Aspirin-exacerbated Respiratory Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Aspirin-exacerbated Respiratory Disease
In brief
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.
Key facts
- Study ID
- NCT03595488
- Run by
- Rochester General Hospital
- People needed
- 11
- Starts
- 2018-09-05
- Expected to finish
- 2019-12-11
- Last updated by the study team
- 2020-08-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- 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.
- Able to understand and willingness to sign informed consent
- Able to comply with study procedures
You may not qualify if…
- Patient < 18 years of age
- Pregnancy or breast feeding
- Current tobacco use
- Significant, uncontrolled medical conditions
- Ongoing malignancy or history of malignancy in remission within the past 12 months
- Current treatment with immunosuppressive medications except chronic oral steroids
- Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)
- Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment
Where it is running
- Rochester Regional Health - Allergy/Immunology — Rochester, New York, United States
Full record on ClinicalTrials.gov
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