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A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 ?g of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps

Study category: Ear, Nose, and Throat

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Description

OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis.

Details
Age

Adult

Eligibility

These are some of the Inclusion criteria: Inclusion Criteria - men or women aged 18 years and older at baseline visit - women must not be pregnant or lactating - must have a history of chronic sinusitis and be currently experiencing 2 or more of the following symptoms, one of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks: nasal congestion, nasal discharge (anterior and/or posterior nasal discharge), facial pain or pressure, reduction or loss of smell - must be able to cease treatment with oral and nasal decongestants and antihistamines at Visit 1 (Screening)

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Vijay Ramakrishnan,  MD

Vijay Ramakrishnan, MD

Study ID

Protocol Number: 18-2823

ClinicalTrials.gov: NCT03781804

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