Preliminary Efficacy of Fluticasone Delivered By a Novel Device in Recalcitrant Chronic Rhinosinusitis.

F.S. Hansen, PG Djupesland, W.J. Fokkens
Rhinology, 48, 000, 2010

Introduction

To assess whether delivery of fluticasone propionate using a novel bi-directional delivery device (Opt-FP) offers therapeutic benefits in patients with chronic rhinosinusitis (CRS).

Methods

• A prospective, single centre, randomized, double-blind, placebo (PBO)-controlled, parallel group study was conducted in adult subjects (n = 20) with CRS without nasal polyps or only cobblestoned mucosa.
• Subjects received Opt-FP 400 μg or placebo twice daily for 12 weeks (n = 10/group). Outcome measures included symptom scores, RSOM-31, CRS VAS, nasendoscopy, peak nasal inspiratory flow (PNIF) and magnetic resonance imaging (MRI).

Results

• Endoscopy score for oedema showed a highly significant and progressive improvement (12 weeks (median scores): Opt-FP -4.0, PBO -1.0, p = 0.015).
• PNIF increased significantly during Opt-FP treatment compared to placebo (4 weeks: p = 0.006; 8 weeks: p = 0.03). After 12 weeks MRI scores in the Opt-FP group improved against baseline (p = 0.039) and a nonsignificant trend was seen versus placebo.
• The nasal RSOM-31 subscale was significantly improved with Opt-FP treatment (4 weeks: p = 0.009, 8 weeks: p = 0.016, 12 weeks: NS).
• Sense of smell, nasal discomfort and combined score were all significantly improved (p < 0.05). The Opt-FP was well tolerated.

Conclusions

The OptiNose breath-actuated bi-directional delivery device administering fluticasone propionate (400 μg b.i.d.) is an effective and well tolerated treatment for recalcitrant CRS.

Clinical Data

Data was presented at Rhinology World Scientific Meeting in Philadelphia, US in April 2009.