CLINICAL TRIALS PROFILE FOR OPN-375

Clinical Trials for OPN-375

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01622569 ↗	Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Labe	Completed	Optinose US Inc.	Phase 3	The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities) over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale score measured by nasoendoscopy.
NCT01623310 ↗	12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device	Completed	Optinose US Inc.	Phase 3	This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.
NCT01624662 ↗	Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device	Completed	Optinose US Inc.	Phase 3	The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.
NCT03591068 ↗	Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video	Completed	Optinose US Inc.	Phase 3	This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
NCT03747458 ↗	OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps	Recruiting	Optinose US Inc.	Phase 3	This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 120 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.
NCT03781804 ↗	Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis With or Without the Presence of Nasal Polyps	Active, not recruiting	Optinose US Inc.	Phase 3	This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic sinusitis (CS) with or without nasal polyps.

Clinical Trial Conditions for OPN-375

Condition Name

Condition Name
Intervention	Trials
Bilateral Nasal Polyposis	4
Chronic Sinusitis	2
Chronic Sinusitis: [Nos] or [Ethmoidal] or [Chronic Pansinusitis] or [Sphenoidal]	1
Nasal Polyposis	1

Condition MeSH

Condition MeSH
Intervention	Trials
Nasal Polyps	7
Chronic Disease	3
Sinusitis	3
Polyps	1

Clinical Trial Locations for OPN-375

Trials by Country

Trials by Country
Location	Trials
United States	121
Poland	10
Canada	6
Russian Federation	5
Sweden	5

Trials by US State

Trials by US State
Location	Trials
Texas	7
Colorado	7
California	6
Utah	5
Virginia	5

Clinical Trial Progress for OPN-375

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	7

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for OPN-375

Sponsor Name

Sponsor Name
Sponsor	Trials
Optinose US Inc.	8

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	8