title: Impact of baseline nasal polyp size and previous surgery on efficacy of fluticasone delivered with a novel device: a subgroup analysis.
abstract: BACKGROUND
  Little information exists on the impact of baseline polyp size and previous nasal surgery on the efficacy of intranasal steroids. This study was designed to investigate whether baseline polyp size and previous nasal surgery influence the efficacy of an intranasal steroid delivered with a novel device.
  
  
  METHODS
  A post hoc analysis of recently published results with intranasal administration using a novel bidirectional delivery device containing fluticasone propionate (Opt-FP) was performed in 109 patients with mild-to-moderate bilateral polyposis. Patients were allocated to subgroups based on summed polyp score at baseline (2, 3, or 4) and on their history of previous sinus surgery.
  
  
  RESULTS
  A highly significant and progressive reduction in summed polyp size was observed for Opt-FP versus placebo in all three polyp size subgroups (p < 0.001). A greater relative reduction in polyp size (p < 0.05) and an increase in peak nasal inspiratory flow (p < 0.001) were observed for Opt-FP at 12 weeks in the 28 patients with a baseline summed score of 3 and 4 compared with the 27 with a summed score of 2. Nevertheless, in patients with small polyps at baseline, the polyps were completely resolved on both sides in 7 of 27 patients. Previous sinus surgery had no impact on efficacy.
  
  
  CONCLUSIONS
  The highly significant progressive treatment effect of Opt-FP was observed regardless of baseline polyps score. Coupled with the complete removal of polyps in many patients with small polyps, this suggests that improved deposition to target sites achieved with the bidirectional delivery device may translate into true clinical benefits and reduced need for surgery.
authors.affiliation: OptiNose AS, Oslo, Norway. pgd@optinose.no
authors.forename: Per G
authors.initials: PG
authors.lastname: Djupesland
authors.forename: Ingrid
authors.initials: I
authors.lastname: Vlckova
authors.forename: Graeme
authors.initials: G
authors.lastname: Hewson
mesh_terms: D000377:Agnosia; D000730:Androstadienes / Q000008:administration & dosage*; D016503:Drug Delivery Systems / Q000706:statistics & numerical data; D004724:Endoscopy; D004864:Equipment and Supplies; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D009831:Olfactory Mucosa / Q000187:drug effects / Q000276:immunology / Q000473:pathology*; D055696:Olfactory Perception / Q000187:drug effects; D011788:Quality of Life; D020127:Recovery of Function / Q000187:drug effects; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D000068298:Fluticasone