Last updated on June 2020

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis Without the Presence of Nasal Polyps

Brief description of study

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 g twice daily (BID) of OPN-375 in subjects with chronic sinusitis (CS) without nasal polyps

Detailed Study Description

The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 g of OPN-375 (fluticasone propionate) with placebo in subjects with chronic sinusitis using the following co-primary endpoints:

  1. A change from baseline in symptoms as measured by a composite score of nasal congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior) at the end of Week 4.
  2. A change from baseline to Week 24/Early Termination (ET) in the average percent of the volume opacified in the ethmoid and maxillary sinuses.

Clinical Study Identifier: NCT03960580

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Recruitment Status: Open

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