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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: Recruiting Phase 3 study of Chronic Rhinosinusitis Without Nasal Polyps, sponsored by Optinose US.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CSS consists of the sum of the scores (0-3) assigned to each of the following symptoms of CRS: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The total CSS for each day can range from 0 to 9. Participants will report symptom severity immediately preceding the time of scoring every morning (AM). The baseline CSS is the average of the CSS's over the last 7 d
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 |
What NCT06850805 shows while recruiting
NCT06850805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT06850805's enrollment target sits among peer trials
84 1750th of 2000 higher than 250 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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