Treatment of chronic rhinosinusitis with intranasal amphotericin B: a randomized, placebo-controlled, double-blind pilot trial.
BACKGROUND
Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its etiology is unknown, and there is a paucity of effective medical treatments.


OBJECTIVE
We tested the hypothesis that intranasal antifungal treatment improves the objective computed tomography (CT) findings (inflammatory mucosal thickening), nasal endoscopy stages, and symptoms of CRS.


METHODS
A randomized, placebo-controlled, double-blind, single-center trial used amphotericin B to treat 30 randomly selected patients with CRS. Patients were instructed to instill 20 mL amphotericin B (250 mug/mL) or placebo to each nostril twice daily for 6 months. The primary outcome was a quantitative reduction in inflammatory mucosal thickening on CT scans of a standardized coronal cut. Secondary outcome measures were endoscopic scores, patient symptom scores, and levels of intranasal inflammatory mediators.


RESULTS
Twenty-four patients completed the 6 months of treatment. Patients receiving amphotericin B achieved a relative reduction in the percentage of mucosal thickening on CT scans (n = 10; -8.8%) compared with placebo (n = 14; +2.5%; P = .030). Likewise, the changes in the endoscopic scores improved in the amphotericin B group compared with placebo ( P = .038). Between-group comparisons of the changes in the intranasal mucus levels of eosinophil-derived neurotoxin showed a reduction in the amphotericin B group and an increase in the placebo group ( P = .046); levels of IL-5 showed similar tendencies ( P = .082).


CONCLUSIONS
Intranasal amphotericin B reduced inflammatory mucosal thickening on both CT scan and nasal endoscopy and decreased the levels of intranasal markers for eosinophilic inflammation in patients with CRS.
Ponikau
Jens U
JU
Department of Otorhinolaryngology-Head and Neck Surgery, Mayo Clinic, Rochester, MN 55905, USA. ponikau.jens@mayo.edu
Sherris
David A
DA
Weaver
Amy
A
Kita
Hirohito
H
D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D004804:Eosinophils / Q000276:immunology; D005260:Female; D006801:Humans; D015848:Interleukin-5 / Q000032:analysis; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D009093:Mucus / Q000276:immunology; D009297:Nasal Mucosa / Q000276:immunology / Q000473:pathology; D010865:Pilot Projects; D012220:Rhinitis / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D012852:Sinusitis / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology
D000935:Antifungal Agents; D015848:Interleukin-5; D000666:Amphotericin B