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NCT06850805 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
A Phase 3 study of Chronic Rhinosinusitis Without Nasal Polyps, sponsored by Optinose US.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT06850805 is a Phase 3 study of Chronic Rhinosinusitis Without Nasal Polyps that is actively recruiting participants, run by Optinose US. The registered enrollment target is 84 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT06850805, a Phase 3 study of Chronic Rhinosinusitis Without Nasal Polyps, is actively recruiting participants, sponsored by Optinose US.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OPN-375
Study Locations (20)
California
- Children's Hospital of Orange County - Orange
- DaVinci Research, LLC - Sacramento
- Breathe Clear Institute - Torrance
Texas
- Orion Clinical Research - Austin
- STAAMP Research - San Antonio
- Alamo ENT Associates - San Antonio
Colorado
- Children's Hospital Colorado - Aurora
- Colorado ENT & Allergy - Colorado Springs
Oklahoma
- Allergy, Asthma and Clinical Research Center - Oklahoma City
- Vital Prospects Clinical Research Institute - Tulsa
South Carolina
- Charleston ENT & Allergy - North Charleston
- Carolina ENT Clinic/CENTRI Inc. - Orangeburg
Arizona
- San Tan Allergy & Asthma - Gilbert
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Southern Illinois University School of Medicine - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06850805
The ClinicalTrials.gov registry entry for NCT06850805 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Optinose US, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Rhinosinusitis Without Nasal Polyps appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06850805 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Texas, Colorado.
Frequently Asked Questions
What is clinical trial NCT06850805 about?
NCT06850805 is a clinical study titled "Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps". 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 o...
What is the current status of trial NCT06850805?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2025-07-28. Estimated completion is 2028-10-31.
What conditions does trial NCT06850805 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis Without Nasal Polyps.
What interventions are being tested in trial NCT06850805?
The interventions under investigation include: Placebo (DRUG), OPN-375 (DRUG).
Who is sponsoring clinical trial NCT06850805?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06850805 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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