Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device

Ingrid Vlckova, Department of Otorhinolaryngology, Palacky University, Olomouc, Czech Republic; Pavel Navrátil, Department of Otorinolaryngology, Hospital Prostejov, Prostejov, Czech Republic; Radim Kaňa, General University Hospital in Prague 2, Department of Otorinolaryngology, Prague 2, Czech Republic; Pavel Pavlicek, E.N.T Department, Hospital Česke Budĕjovice, Czech Republic; Pavel Chrbolka, Department of Otorhinolaryngology, Thomayer´s University Hospital, Videnska 800, Prague 4, Czech Republic; Per G. Djupesland, OptiNose AS, Oslo, Norway

Objective

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.

Methods

• 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.

Results

• 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.

Conclusions

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.

Clinical Data

Data was presented at the 56th Annual Scientific Meeting of the American Rhinologic Society in Chicago, US in September, 2009.