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Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
NCT06850805 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06850805 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Texas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06850805?
The interventions under investigation include: Placebo (DRUG), OPN-375 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06850805?
This trial is sponsored by Optinose US, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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