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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-03-23

No results posted yet for this 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

  • Chronic Rhinosinusitis Without Nasal Polyps

Interventions

DRUG

OPN-375

OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID

DRUG

Placebo

Placebo solution administered via exhalation delivery system (EDS).

Sponsors & Collaborators

  • Optinose US Inc.

    lead INDUSTRY

Principal Investigators

  • Amy Manley · Paratek Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2028-03-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850805 on ClinicalTrials.gov