A 30 Week Multicenter Study Evaluating the Effectiveness of OPN-375 on Bilateral Nasal Polyps

Clinical Trial

Offered by: Nemours Children's
Location: Jacksonville

Trial Name

A 30 Week Multicenter Study Evaluating the Effectiveness of OPN-375 on Bilateral Nasal Polyps

What is the trial about?

This study is being done to evaluate the efficacy and safety of OPN-375 (fluticasone propionate nasal spray with an OptiNose Exhalation Delivery System (EDS) that delivers drug into the nose) delivered in 186 mcg doses twice a day in adolescents with Bilateral Nasal Polyps.

Who can participate?

Children between the ages of 12 and 17 who have been diagnosed with nasal polyps in both sides of their nose.

What is involved?

This study has three different phases or parts. During the first part (screening), tests will be done to see if your child qualifies. If so, he/she will then enter the second part, during which your child will be taking either OPN-375 or placebo for about 16 weeks. After this part of the study is completed, your child will enter the third part of the study in which he/she will be given OPN-375, not placebo, for 12 weeks. There are 8 on site clinic visits lasting up to 2 hours each, and 2 telephone check in calls.

There are 2 scheduled blood draws and urine tests, 2 eye exams and 2 physical exams for the study. You or your child will be asked to complete questionnaires, there will be 7 nasal exams with 5 nasoendoscopy exams for your child. You or your child will be asked to keep a daily electronic diary of nasal symptoms.