Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

NCT03675022 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 2018P001031
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea; Rhinosinusitis Chronic

Outcome Measures

Primary Outcomes (1)

• Percent change in apnea-hypopnea index (AHI) after 16 weeks of dupilumab therapy

  The effect of dupilumab on OSA severity in patients with nasal obstruction due to chronic rhinosinusitis with or without nasal polyposis (Bilateral CRS). AHI is the amount of respiratory events that a patient has per hours of sleep.

  16 weeks

Secondary Outcomes (10)

• Effect of 16 weeks of dupilumab on sleep architecture total sleep time

  16 weeks

• Effect of 16 weeks of dupilumab on sleep architecture sleep stage percentages

  16 weeks

• Effect of 16 weeks of dupilumab on sleep architecture arousal index

  16 weeks

• Effect of 16 weeks of dupilumab on sleep architecture oxygen saturation

  16 weeks

• Epworth Sleepiness Score (ESS)

  16 weeks

Other Outcomes (4)

• Sino-Nasal Outcome Test (SNOT-22)

  16 weeks

• Visual analog scale (VAS) for rhinosinusitis

  16 weeks

• University of Pennsylvania Smell Identification Test (UPSIT)

  16 weeks

Study Arms (1)

Dupilumab

EXPERIMENTAL

Dupilumab injections every 2 weeks.

Drug: Dupilumab

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).

Also known as: Dupixent

Dupilumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 to 65 years)
• BMI \< 35 kg/m2
• Bilateral CRS (clinical diagnosis) with or without nasal polyposis despite intranasal corticosteroid treatment for at least 3 months.
• Patients will be required to report at least 2 of the following symptoms prior to screening: (1) nasal obstruction/blockage, (2) nasal discharge or discolored postnasal drainage, (3) facial pain or pressure, and (4) reduction or loss of sense of smell, with symptom duration of at least 3 months.
• Suffering from OSA with AHI \> 10 episodes/hr based on the home sleep test (described below) and not using CPAP.
• Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
• In females of childbearing potential: Negative pregnancy test. A urine pregnancy test will be performed in each site visit to ensure that the patients are not pregnant while using dupilumab.

You may not qualify if:

• Concurrent sleep disorder
• Previous participation in any clinical trial of dupilumab in which active treatment was administered.
• Oral corticosteroids, monoclonal antibodies, immunosuppressive treatment, or anti-immunoglobulin E (anti-IgE) therapy during the 6 weeks preceding the screening.
• Lactating females or pregnant females.
• Subjects for whom there is concern about compliance with the protocol procedures.
• Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk (chronic infectious diseases such as TB, HIV, Hepatitis, etc.).
• History of hypersensitivity to the study drug.
• History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject's ability to comply with study procedures.
• Subjects must refrain from intranasal decongestants for 1 week prior to starting the study.
• Subjects with a medical history of HSV1 or HSV2, or with a history of recurrent conjunctivitis.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Translational Research in Allergy

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: September 18, 2018
• Study Start: August 15, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

US (1)