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OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps

Research Question:
This study is being conducted to see if OPN-375 (fluticasone propionate nasal spray with an OptiNose Exhalation Delivery System (“EDS”) that delivers drug into the nose), given at a dose of 186 mcg twice a day, is safe and effective in reducing specific nasal symptoms and the size of nasal polyps in children between the ages of 12 and 17.

Basic Study Information

Purpose:
This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 120 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.

Location: University of Rochester
Study Reference #: WIRB 20181915

Lead Researcher (Principal Investigator)

Lead Researcher: Li-Xing Man

Study Contact Information

Study Coordinator: Paul Allen
Phone: (585) 275-1186
Email: paul_allen@urmc.rochester.edu

Additional Study Details

Number of Visits:  6 to 10
Parking:  Free
Transportation Coverage: 
Reimbursement:  Yes

Learn More About These Conditions

More information about Nasal Polyps

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