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

NCT03591068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-08-03

Study results available
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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.

Conditions

  • Nasal Polyposis

Interventions

DRUG

Fluticasone Propionate

OPN-375 186 μg BID, Delivered via exhalation delivery system

Sponsors & Collaborators

  • Optinose US Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Carothers · Optinose US Inc.

  • John Messina · Optinose US Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2019-02-22
Completion
2019-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591068 on ClinicalTrials.gov