OptiNose without Polyps
The main goal of this study is to see how well a nasal spray called OPN-375 (fluticasone propionate) works compared to a placebo when used twice a day by teenagers who have chronic sinus inflammation (chronic rhinosinusitis) without nasal polyps. The study will also check how safe OPN-375 is. This includes watching for any side effects, doing regular nose and eye exams, checking vital signs like blood pressure and pulse, tracking weight, and keeping note of any other medicines the participants are taking.
Why this Research Matters
Participants will come to the clinic three (3) times: Screening, Baseline and 12 weeks later. The study team will call the participants at 4 and 8 weeks from their Baseline visit. At the first visit (Screening) and their last visit (week 12), participants will have a nasal exam, an eye exam, answer questionnaires, collect vital signs, receive or turn in the study drug/placebo, and get their blood drawn (medication can be used to make the area numb). In the Baseline visit, participants will answer questionnaires, collect vital signs, and receive the study drug/placebo.
Who can Participate
Inclusion: * Male or female aged 12-17 years * Non-pregnant females * Must have a history of Chronic Rhinosinusitis These are only part of the eligibility criteria.
Study ID
Protocol Number: 25-0014
More information available at ClinicalTrials.gov: NCT06850805
Meet the Team
Principal Investigator