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 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 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 µg b.i.d.) is an effective and well tolerated treatment for recalcitrant CRS.
RCT Entities:
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 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 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 µg b.i.d.) is an effective and well tolerated treatment for recalcitrant CRS.
Authors: Khodayar Goshtasbi; Mehdi Abouzari; Arash Abiri; Tyler Yasaka; Ronald Sahyouni; Benjamin Bitner; Bobby A Tajudeen; Edward C Kuan Journal: Int Forum Allergy Rhinol Date: 2019-09-20 Impact factor: 3.858
Authors: Cezmi A Akdis; Claus Bachert; Cemal Cingi; Mark S Dykewicz; Peter W Hellings; Robert M Naclerio; Robert P Schleimer; Dennis Ledford Journal: J Allergy Clin Immunol Date: 2013-04-12 Impact factor: 10.793
Authors: Lee Yee Chong; Karen Head; Claire Hopkins; Carl Philpott; Anne G M Schilder; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2016-04-26