Conditions: Bilateral Nasal Polyposis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief summary:
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.

Detailed description:
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of intranasal administration of 3 doses of OPN-375 (100, 200, and 400 µg bid) in subjects with bilateral nasal polyposis and nasal congestion.

This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) entered the study.

1. Pretreatment phase (single-blind, placebo, run-in): 7 to up to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase.
2. Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2, Day 1 (baseline) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16).
3. Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 \[Week 24\]).

Arms:
arm 1: Double-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks arm 2: Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks arm 3: Double-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks arm 4: Double-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks

Interventions: intervention 1: Fluticasone Propionate
Intervention descriptions: intervention 1: Delivered via Optinose Exhalation Delivery System

Protocol document: