Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05575037
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Aspirin-Exacerbated Respiratory Disease
  • Aspirin-Sensitive Asthma With Nasal Polyps
  • Asthma, Aspirin-Induced
  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    8-week trial of dupilumab (an anti-IL-4a) in patients with AERD.

Study Details

The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).

Key Dates

First listed
Oct 12, 2022
Start date
Aug 1, 2023
Status verified
Aug 2026
Primary completion
Apr 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Subjects will receive dupilumab (300mg every-other-week for 8 weeks).

Primary Outcome Measure

Nasal fluid levels of LTE4 [ Time Frame: At Week 8 (Visit 3) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

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By research site
Brigham and Women's Hospital· Boston, MA

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