Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 5:04 AM
Study NCT ID:
NCT06850805
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Sponsor:
Optinose US Inc.
Organization:
Study Overview
Official Title:
A 12-Week Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 mcg of OPN-375 Twice a Day (BID) in Adolescent Subjects With Chronic Rhinosinusitis Without Nasal Polyps
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Re-Open 3
Brief 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.
Detailed Description:
The primary objective of this study is to compare the efficacy of intranasal administration of OPN-375 (fluticasone propionate)186 µg twice a day (BID) versus placebo in adolescents with chronic rhinosinusitis (CRS) without nasal polyps (sNP) using the endpoint of change from baseline in CRS symptoms as measured by a 7-day average instantaneous composite score of nasal symptoms (CSS) at the end of Week 4. The CSS is the sum of scores assigned to the symptoms congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior), on a scale of 0 (non-symptomatic) to 3 (severe symptoms). The total CSS can range from 0-9. Eligible study subjects will complete a 7 to 21 day screening period followed by a 12-week double-blind treatment period, for a total of approximately 15 weeks of participation. The study consists of 3 on-site study visits (screening/V1, randomization/V2, end of study/V3/Week 12) and two telephone calls at participation weeks 4 and 8.
The study will include a pharmacokinetic (PK) substudy in which PK assessment of 186 µg OPN-375 in up to 14 study subjects will be conducted in an open label fashion.
The study will include a pharmacokinetic (PK) substudy in which PK assessment of 186 µg OPN-375 in up to 14 study subjects will be conducted in an open label fashion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: