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Completed Phase 3 Interventional Results available

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

ClinicalTrials.gov ID: NCT03781804

Public ClinicalTrials.gov record NCT03781804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 9, 2026, 5:02 AM EST

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Official title

A 24-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.

Study identification

NCT ID
NCT03781804
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Optinose US Inc.
Industry
Enrollment
332 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 27, 2018 (Actual)
Primary completion
Jan 19, 2022 (Actual)
Completion
Jan 19, 2022 (Actual)
Last update posted
May 29, 2024

2018 – 2022

United States locations

U.S. sites
46
U.S. states
26
U.S. cities
43
Facility City State ZIP Site status
AZ Allergy & Immunology Research Gilbert Arizona 85234 —
Kern Research Bakersfield California 93301 —
Sacramento Ear, Nose & Throat Surgical and Medical Group Inc Folsom California 95630 —
Allergy & Asthma Specialists Medical Group Huntington Beach California 92647 —
Jonathan Corren, MD, Clinical Research Division Los Angeles California 90025 —
Sacramento Ear, Nose & Throat Roseville California 95661 —
UC Davis Medical Center Sacramento California 95817 —
Allergy and Asthma Associates of Santa Clara Valley San Jose California 95117 —
Breathe Clear Institute Torrance California 90503 —
Allergy & Asthma Clinical Research Walnut Creek California 94598 —
Colorado ENT & Allergy Colorado Springs Colorado 80909 —
Yale School of Medicine Section of Otolaryngology New Haven Connecticut 06519 —
Emory University MOT Atlanta Georgia 30308 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Rush University Medical Center Chicago Illinois 60612 —
The University of Chicago Chicago Illinois 60637 —
Midwest Allergy Sinus Asthma Normal Illinois 61761 —
Advanced ENT and Allergy New Albany Indiana 47150 —
Iowa Head & Neck Des Moines Iowa 50312-3505 —
Kentuckiana Ear Nose & Throat Louisville Kentucky 40205 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
John Hopkins Hospital Baltimore Maryland 21287 —
Ear, Nose and Throat Associates at Greater Baltimore Medical Center Towson Maryland 21204 —
St. Cloud Ear, Nose & Throat Saint Cloud Minnesota 56303 —
University of Missouri, Dept of Otorlaryngology Columbia Missouri 65212 —
Asthma, Allergy, and Immunology Associates, PC Lincoln Nebraska 68505 —
Atlantic Research Center Ocean City New Jersey 07712 —
ENT and Allergy Associates New Hyde Park New York 11042 —
Mount Sinai Downtown Union Square New York New York 10003 —
Madison ENT and Facial Plastic Surgery New York New York 10016 —
Allergy Asthma & Immunology Relief of Charlotte Charlotte North Carolina 28204 —
Allergy Asthma & Clinical Research Center Oklahoma City Oklahoma 73120 —
Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma 74136 —
Northwest Research Center Portland Oregon 97202 —
Specialty Physician Associates Bethlehem Pennsylvania 18017 —
Hospital at the University of PA Philadelphia Pennsylvania 19104 —
Medical University of South Carolina Charleston South Carolina 29425 —
National Allergy and Asthma Research North Charleston South Carolina 29420 —
Holston Medical Group Kingsport Tennessee 37660 —
University of TX Health Science Ctr at Houston Houston Texas 77030 —
STAAMP Research, LLC San Antonio Texas 78229 —
Intermountain Ear, Nose & Throat Salt Lake City Utah 84102 —
Chrysallis Clinical Research St. George Utah 84790 —
Eastern Virginia Medical School Norfolk Virginia 23507 —
Bellingham Asthma, Allergy & Immunology Clinic Bellingham Washington 98225 —
Spokane ENT Spokane Valley Washington 99201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03781804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 29, 2024 · Synced Nov 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03781804 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →