NCT03595488

Dupilumab for Aspirin-exacerbated Respiratory Disease

Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Rochester General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single blind, placebo controlled trial to be conducted in adult patients with AERD to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis. All subjects will be treated with the FDA-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 Patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose. There will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters. Patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. These medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. These controller medications will not be dispensed or supplied by the sponsor.

Conditions

• Aspirin-exacerbated Respiratory Disease

Interventions

Type	Name	Description
DRUG	Dupilumab	dupilumab 300 mg subcutaneous injection every 2 weeks

Timeline

• Start date: 2018-09-05
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2018-07-23
• Last updated: 2020-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study