Ear, Nose and Throat Associates at Greater Baltimore Medical Center(9.3 mi away)Contact
+62 other location
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) with or without nasal
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:
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.
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
Optinose US Inc.
Last Modified on
30 September 2020
How clear was the trial content above?
Adding a note
Select a piece of text and start making personal notes.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.