Overview

Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps

Status:
RECRUITING
Trial end date:
2028-10-31
Target enrollment:
Participant gender:
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 g 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 g:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.
Phase:
PHASE3
Details
Lead Sponsor:
Optinose US Inc.