Dupilumab for Aspirin-exacerbated Respiratory Disease

Conditions

• Aspirin-exacerbated Respiratory Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Dupilumab — DRUG
  dupilumab 300 mg subcutaneous injection every 2 weeks

Study Details

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 Dates

Start date

Sep 5, 2018

Status verified

Aug 2020

Primary completion

Dec 11, 2019

Completion

Dec 11, 2019

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment arm
  Single-blinded, Dupilumab or matching placebo will be administered to the patients at the study visits. At each study visit, a single dose of dupilumab or placebo will be dispensed to the patients to be administered at home. 300 mg/2 ml solution in a single-dose pre-filled syringe with needle shield given once every 2 weeks in a subcutaneous injection

Primary Outcome Measure

SNOT 22 Score [ Time Frame: From baseline to completion of study(7 months total) ]

Locations (1)

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