Ingrid Vlckova, Pavel Navrátil, Radim Kaňa, Pavel Pavlicek, Pavel Chrbolka, Per G. Djupesland
Rhinology, 47, 419-426, 2009.
To assess the efficacy and safety of fluticasone propionate administered using OptiNose’s novel delivery device (Opt-FP) in subjects with bilateral mild-to-moderate nasal polyposis.
A prospective, multicentre, randomized, double blind, placebo-controlled, parallel group study was conducted in adult subjects (n = 109) with mild-to-moderate bilateral nasal polyposis. Subjects received Opt-FP 400 μg or placebo twice daily for 12 weeks. Endpoints included endoscopic assessment of polyp size using Lildholdt’s Scale, peak nasal inspiratory flow (PNIF), symptom scores and use of rescue medication.
The proportion of subjects with improvement in summed polyp score ≥ 1 (Lildholdt’s Scale) was significantly higher with Opt-FP compared with placebo at 4, 8 and 12 weeks (22% vs 7%, p = 0.011, 43% vs 7%, p < 0.001, 57% vs 9%, p < 0.001). After 12 weeks the summed polyp score was reduced by 35% (-0.98 vs +0.23, p < 0.001). PNIF increased progressively during Opt-FP treatment (p < 0.05). Combined symptom score, nasal blockage, discomfort, rhinitis symptoms and sense of smell were all significantly improved. Rescue medication use was lower (3.1% vs 22.4%, p < 0.001). Opt-FP was well tolerated.
Fluticasone propionate (400 μg b.i.d.) administered using OptiNose’s breath actuated bi-directional delivery device was an effective and well tolerated treatment for mild-to moderate bilateral nasal polyposis.