Efficacy and Safety of OPN-375 186 ug Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps

To evaluate the efficacy of intranasal administration of OPN-375 186 ?g twice a day (BID) versus placebo in adolescents with bilateral nasal polyposis and nasal congestion using the co-primary endpoints: 

1) reduction of nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA); and

2) reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale (with 0 to 3 points per nostril).

Eligibility criteria 

Male or female subjects aged 12 to 17 years, inclusive

              Must have bilateral nasal polyposis

              Must report at least mild symptoms of nasal congestion/obstruction