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Also known as Fluticasone propionate
OPN-375 · 4 trials · 3 indications
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 days of the single-blind run-in period. The end of Week 4 CSS is the average of the CSS's over the 7 days before Week 4.
Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
Change in nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA). The nasal symptom scale is what is used to score the nasal congestion/obstruction score, which is recorded in the diary. Nasal symptom scale is graded on a scale of 0=no symptom, 1=mild symptom, 2=moderate symptom, 3=severe symptom.
Change in total polyp grade (sum of scores from both nasal cavities) at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril
Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
| Arm | Type | Description |
|---|---|---|
| Placebo BID | PLACEBO_COMPARATOR | Double-Blind Treatment Phase: Intranasal administration of matching placebo BID x 12 weeks |
| OPN-375 186 µg BID | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: Intranasal administration of OPN-375 186 µg x 12 weeks |
| OPN-375 186 μg BID | ACTIVE_COMPARATOR | OPN-375 186 μg BID x 24 Weeks |
| OPN-375 372 μg BID | ACTIVE_COMPARATOR | OPN-375 372 μg BID x 24 Weeks |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo BID x 24 Weeks |
| Name | Type | Description |
|---|---|---|
| OPN-375 | DRUG | OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID |
| Placebo | DRUG | Placebo solution administered via exhalation delivery system (EDS). |
Inclusion Criteria: 1. Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening) 2. Female subjects, if sexually active, must: 1. be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patc...
OPN-375 is an investigational small molecule nasal spray developed by OptiNose, Inc. (ticker OPTN). It is being studied for chronic rhinosinusitis, including chronic rhinosinusitis without nasal polyps and bilateral nasal polyposis. It is in Phase 3 clinical development and has not been approved by the FDA.
OPN-375 is being developed to treat chronic rhinosinusitis, including chronic rhinosinusitis without nasal polyps and bilateral nasal polyposis. Clinical trials have enrolled adolescents and adults with these conditions. It remains investigational and is not approved for commercial use.
OPN-375 is developed by OptiNose, Inc., which trades under the ticker OPTN. The company is the sponsor of the Phase 3 clinical program evaluating the intranasal small molecule in chronic rhinosinusitis and bilateral nasal polyposis.
OPN-375 is in Phase 3 clinical development. One Phase 3 trial, NCT06850805, is currently recruiting adolescents with chronic rhinosinusitis without nasal polyps, while three other Phase 3 studies have been completed. The drug is investigational and has not been approved by the FDA.
OPN-375 has been evaluated in Phase 3 trials including NCT06850805, which is recruiting adolescents with chronic rhinosinusitis without nasal polyps, and the completed studies NCT03960580, NCT03781804, and NCT03747458. These trials enrolled adults and adolescents across the United States, Europe, and other regions.
OPN-375 is not FDA approved. It is an investigational small molecule in Phase 3 clinical development for chronic rhinosinusitis and bilateral nasal polyposis, sponsored by OptiNose, Inc. (ticker OPTN). Approval status would depend on completion of the clinical program and regulatory review.