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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
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
Study ID
Protocol Number: 18-2823
ClinicalTrials.gov: NCT03781804
Categories
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