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

Conditions

• Chronic Rhinosinusitis Without Nasal Polyps

Eligibility Criteria

Sex

ALL

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• OPN-375 — DRUG
  OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID
• Placebo — DRUG
  Placebo solution administered via exhalation delivery system (EDS).

Study Details

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.

Key Dates

Start date

Jul 28, 2025

Status verified

Mar 2026

Primary completion

Mar 31, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo BID
  Double-Blind Treatment Phase: Intranasal administration of matching placebo BID x 12 weeks
• Active Comparator: OPN-375 186 µg BID
  Double-Blind Treatment Phase: Intranasal administration of OPN-375 186 µg x 12 weeks

Primary Outcome Measure

Change from baseline to the end of Week 4 in the average instantaneous CSS (evaluation of symptom severity immediately preceding the time of scoring). [ Time Frame: 4 Weeks ]

Central Contacts

• Alissa Sirbu
  484-751-4926
  [email protected]
• Amy Manley
  [email protected]

Locations (21)

Find similar trials in Gilbert, AZ

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