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

Brief summary:
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.

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 fluticasone propionate (100, 200, and 400 μg bid), delivered by the Optinose device, 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) visit entered the study.

1. Pretreatment phase (single-blind, placebo, run-in): 7 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) 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 \[Week 24\]), during which all subjects received fluticasone propionate 400 mcg BID delivered by the Optinose device

Arms:
arm 1: Double-Blind Treatment Phase: OPN-375 100 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks arm 2: Double-Blind Treatment Phase: OPN-375 200 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks arm 3: Double-Blind Treatment Phase: OPN-375 400 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks arm 4: Double-Blind Treatment Phase: Matched Placebo BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks

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

Protocol document: