Clinical Trials Logo
  1. Home
  2. Nasal Polyposis
  3. NCT03591068

Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

Nasal Polyposis Clinical Trial

Official title:
A 24-Week Open-Label Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

Clinical Trial Summary

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.

Clinical Trial Description

The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03591068
Study type Interventional
Source Optinose US Inc.
Contact
Status Completed
Phase Phase 3
Start date June 7, 2018
Completion date February 22, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT04532736 - Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis Phase 2
Completed NCT02784262 - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis Phase 2
Active, not recruiting NCT04157335 - Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID) Phase 3
Completed NCT02562924 - The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery N/A
Completed NCT00480298 - Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis Phase 2
Completed NCT03358329 - Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) Phase 3
Active, not recruiting NCT01906697 - The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates Phase 3
Recruiting NCT05056714 - Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)
Completed NCT03401229 - Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis Phase 3
Recruiting NCT03979716 - Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging N/A
Not yet recruiting NCT05131958 - Nasality Evolution in a Nasal Polyposis Context : Multiparametric Evaluation : Articulatory (Imaging), Aerodynamics, Acoustics and Perception
Completed NCT02291549 - S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps Phase 3
Completed NCT01393340 - Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma Phase 2
Completed NCT02734849 - Study to Evaluate Multiple Doses in Patients With Nasal Polyposis Phase 2