title: Intranasal antifungal treatment in 51 patients with chronic rhinosinusitis.
abstract: BACKGROUND
  Chronic rhinosinusitis (CRS) is the most common chronic disease that is frequently refractory to treatment.
  
  
  OBJECTIVE
  We sought to establish the safety and demonstrate the clinical efficacy of intranasal antifungal drug therapy in patients with CRS in a pilot trial.
  
  
  METHODS
  A prospective open-label trial used amphotericin B as a medical treatment in 51 randomly selected patients with CRS. The antifungal agent was applied intranasally as 20 mL of a 100 microg/mL solution twice daily. The outcome was measured by using their symptoms and by using an endoscopic scoring system in all patients. In addition, pretreatment and posttreatment coronal computed tomographic scans of the nose and sinuses were available for evaluation in 13 patients.
  
  
  RESULTS
  By using amphotericin B, improvement of sinusitis symptoms was observed in 38 (75%) of 51 patients. Endoscopically, 18 (35%) of 51 patients became disease free, and an additional 20 (39%) of 51 had improvement of at least one stage (P <.001). No effect was seen in 13 (25%) of 51 patients. The available computed tomographic scans before and after treatment demonstrated a significant reduction in the inflammatory mucosa thickening that had occluded the paranasal sinuses (P <.0001 in maxillary sinus).
  
  
  CONCLUSIONS
  This open-label pilot trial demonstrates that direct mucoadministration of an antifungal drug appears to be both safe and effective in the treatment of patients with CRS. Therefore controlled and blinded trials are indicated to clarify the novel role of intranasal antifungal drugs in the treatment of CRS.
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Mayo Clinic Rochester, Rochester, MN 55905, USA.
authors.forename: Jens U
authors.initials: JU
authors.lastname: Ponikau
authors.forename: David A
authors.initials: DA
authors.lastname: Sherris
authors.forename: Hirohito
authors.initials: H
authors.lastname: Kita
authors.forename: Eugene B
authors.initials: EB
authors.lastname: Kern
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000627:therapeutic use*; D002648:Child; D002908:Chronic Disease; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed
chemical_list: D000935:Antifungal Agents; D000666:Amphotericin B