Optinose US Inc.: Clinical Trials

11 completed, 1 recruiting, 1 terminated. 10 Phase 3, 3 Phase 1.

By phase and status

Phase	Trials	Status
Phase 3	10	Completed 9, Recruiting 1
Phase 1	3	Completed 2, Terminated 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps OPN-375, Placebo - Chronic Rhinosinusitis Without Nasal Polyps	Phase 3	Recruiting	Optinose US Inc.	84	2025-07-28	2026-09-18
A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19 OPN-019 - Covid19	Phase 1	Terminated	Optinose US Inc.	8	2021-09-01	2022-05-02
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps OPN-375 - Chronic Rhinosinusitis	Phase 3	Completed	Optinose US Inc.	223	2019-06-06	2023-12-21
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps OPN-375 - Bilateral Nasal Polyposis	Phase 3	Completed	Optinose US Inc.	40	2018-12-31	2026-09-18
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps OPN-375 - Chronic Rhinosinusitis	Phase 3	Completed	Optinose US Inc.	332	2018-11-27	2024-05-29
Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video Fluticasone Propionate - Nasal Polyposis	Phase 3	Completed	Optinose US Inc.	11	2018-06-07	2020-08-03
A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) Flovent HFA, OPTINOSE™ FLUTICASONE - Mild to Moderate Asthma	Phase 1	Completed	Optinose US Inc.	28	2014-09-01	2016-02-03
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-Label Extension Phase to Assess Safety Fluticasone Propionate - Bilateral Nasal Polyposis	Phase 3	Completed	Optinose US Inc.	323	2013-11-19	2018-12-26
Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device Fluticasone propionate - Bilateral Nasal Polyposis	Phase 3	Completed	Optinose US Inc.	323	2013-10-30	2018-12-05
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps Fluticasone Propionate - Chronic Sinusitis With or Without Nasal Polyps	Phase 3	Completed	Optinose US Inc.	705	2013-09-01	2016-08-29
12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device Fluticasone Propionate - Nasal Polyps	Phase 3	Completed	Optinose US Inc.	223	2013-09-01	2018-01-24
Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects Sumatriptan - Migraine	Phase 1	Completed	Optinose US Inc.	20	2012-01-01	2012-02-29
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine Sumatriptan, Placebo - Migraine Headache	Phase 3	Completed	Optinose US Inc.	223	2011-01-01	2015-05-06

Conditions studied

Migraine Disorders (2)  ·  Nasal Polyps (2)  ·  COVID-19 (1)  ·  Headache (1)

Interventions

Fluticasone (6)  ·  Sumatriptan (2)

Countries

United States (11)  ·  Bulgaria (2)  ·  Canada (2)  ·  Georgia (2)  ·  Poland (2)  ·  United Kingdom (2)  ·  Argentina (1)  ·  Australia (1)  ·  Czechia (1)  ·  Ireland (1)  ·  Mexico (1)  ·  New Zealand (1)  ·  Romania (1)  ·  Russia (1)  ·  Spain (1)

Top investigators

Jennifer Carothers (4)  ·  John Messina (4)  ·  Amy Manley (2)  ·  Adrian J Stewart, BM, MRCGP, MFPM (1)

Results publications

PMID 34753535, PMID 35437059, PMID 42647052, PMID 42692406, PMID 23992438, PMID 25355310, PMID 29928924, PMID 31732149