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Recruiting Phase 3 Interventional

Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps

ClinicalTrials.gov ID: NCT06850805

Public ClinicalTrials.gov record NCT06850805. 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.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 6:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 12-Week Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 mcg of OPN-375 Twice a Day (BID) in Adolescent Subjects With Chronic Rhinosinusitis Without Nasal Polyps

Brief summary

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

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.

Study identification

NCT ID
NCT06850805
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Optinose US Inc.
Industry
Enrollment
84 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 17 Years
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
Jul 28, 2025 (Actual)
Primary completion
Mar 31, 2028 (Estimated)
Completion
Oct 31, 2028 (Estimated)
Last update posted
Sep 18, 2026

2025 – 2028

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
23
Facility City State ZIP Site status
North Alabama ENT Huntsville Alabama 35801 Not yet recruiting
San Tan Allergy & Asthma Gilbert Arizona 85214 Withdrawn
Childrens Hospital of Los Angeles Los Angeles California 90027 Not yet recruiting
Children's Hospital of Orange County Orange California 92868 Recruiting
DaVinci Research, LLC Sacramento California 95661 Recruiting
Rady Childrens Hospital San Diego San Diego California 92123 Not yet recruiting
Breathe Clear Institute Torrance California 90503 Recruiting
Children's Hospital Colorado Aurora Colorado 80045 Recruiting
Colorado ENT & Allergy Colorado Springs Colorado 80909 Recruiting
Children's Healthcare of Atlanta Atlanta Georgia 30329 Not yet recruiting
Southern Illinois University School of Medicine Springfield Illinois 62702 Recruiting
Kentuckiana ENT Louisville Kentucky 40205 Recruiting
Centers for Advanced ENT Care Towson Maryland 21204 Recruiting
University of Missouri Medical Center Columbia Missouri 65212 Recruiting
University of Rochester Medical Center Rochester New York 14642 Recruiting
Allergy, Asthma and Clinical Research Center Oklahoma City Oklahoma 73120 Recruiting
Vital Prospects Clinical Research Institute Tulsa Oklahoma 74136 Recruiting
Charleston ENT & Allergy North Charleston South Carolina 29414 Recruiting
Carolina ENT Clinic/CENTRI Inc. Orangeburg South Carolina 29118 Recruiting
Orion Clinical Research Austin Texas 78759 Recruiting
STAAMP Research San Antonio Texas 78229 Recruiting
Alamo ENT Associates San Antonio Texas 78258 Recruiting
University of Utah Salt Lake City Utah 84112 Recruiting
EVMS at Old Dominion University Norfolk Virginia 23507 Recruiting

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06850805, 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 Sep 18, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06850805 live on ClinicalTrials.gov.

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