Preliminary efficacy of fluticasone delivered by a novel device in recalcitrant chronic rhinosinusitis

Objective: 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 jig or placebo twice daily jar 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 non-significant 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 mu g b.i.d.) is an effective and well tolerated treatment for recalcitrant CRS