Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03675022
Phase
EARLY_PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    The investigational drug is dupilumab, 300mg in 2ml solution for subcutaneous application. All Patients will receive dupilumab, 300mg, every two weeks (8 subcutaneous injections total).

Study Details

Obstructive Sleep Apnea (OSA) is a common disorder with serious consequences that remains underrecognized, with \>80% of OSA patients undiagnosed, and undertreated due to inadequate treatment options. The development of additional treatments for OSA, such as pharmacotherapy, are critically needed. The collaboration between Regeneron and Sanofi are funding this project. Regeneron will be providing the drug and the contract will be with Regeneron. Both companies are involved as it is a collaboration across the companies.

Key Dates

Start date
Aug 15, 2018
Status verified
Oct 2022
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

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

Arms

  • Experimental: Dupilumab
    Dupilumab injections every 2 weeks.

Primary Outcome Measure

Percent change in apnea-hypopnea index (AHI) after 16 weeks of dupilumab therapy [ Time Frame: 16 weeks ]

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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