Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Labe
Completed
Optinose US Inc.
Phase 3
The primary objective of this study is to compare the efficacy of intranasal administration
of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose
device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will
be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4
of the double-blind treatment phase measured by the 7 day average instantaneous AM diary
symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities)
over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale
score measured by nasoendoscopy.
12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
Completed
Optinose US Inc.
Phase 3
This is an open-label, multicenter study designed to assess the safety of intranasal
administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose
device in subjects with chronic sinusitis with or without nasal polyps. The study consists of
an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The
duration of each subject's participation is approximately 53 weeks.
Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
Completed
Optinose US Inc.
Phase 3
The primary objective of this study was to compare the efficacy of intranasal administration
of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the
Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal
congestion.
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