Condition: Chronic Rhinosinusitis Without Nasal Polyps · Sponsor: Optinose US Inc.
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.
This description comes directly from the study's public registry record.
Alissa Sirbu · 484-751-4926 · alissa.sirbu@paratekpharma.com
Amy Manley · amy.manley@paratekpharma.com
Always discuss trial participation with your own doctor first.
| San Tan Allergy & Asthma | Gilbert, Arizona, United States | Withdrawn |
| Children's Hospital of Orange County | Orange, California, United States | Recruiting |
| DaVinci Research, LLC | Sacramento, California, United States | Recruiting |
| Breathe Clear Institute | Torrance, California, United States | Recruiting |
| Children's Hospital Colorado | Aurora, Colorado, United States | Recruiting |
| Colorado ENT & Allergy | Colorado Springs, Colorado, United States | Recruiting |
| Children's Healthcare of Atlanta | Atlanta, Georgia, United States | Not Yet Recruiting |
| Southern Illinois University School of Medicine | Springfield, Illinois, United States | Recruiting |
| Kentuckiana ENT | Louisville, Kentucky, United States | Recruiting |
| Centers for Advanced ENT Care | Towson, Maryland, United States | Recruiting |
| University of Missouri Medical Center | Columbia, Missouri, United States | Not Yet Recruiting |
| University of Rochester Medical Center | Rochester, New York, United States | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06850805