Treatment of chronic rhinosinusitis with intranasal amphotericin B: A randomized, placebo-controlled, double-blind pilot trial

Jens U. Ponikau, David A. Sherris, Amy Weaver, Hirohito Kita

Research output: Contribution to journalArticle

186 Citations (Scopus)

Abstract

Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its etiology is unknown, and there is a paucity of effective medical treatments. 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. 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 μg/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. 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). 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.

Original languageEnglish (US)
Pages (from-to)125-131
Number of pages7
JournalJournal of Allergy and Clinical Immunology
Volume115
Issue number1
DOIs
StatePublished - Jan 2005

Fingerprint

Amphotericin B
Placebos
Tomography
Nose
Endoscopy
Therapeutics
Eosinophil-Derived Neurotoxin
Interleukin-5
Mucus
Chronic Disease
Outcome Assessment (Health Care)
Inflammation

Keywords

  • amphotericin B
  • antifungal
  • chronic rhinosinusitis
  • chronic sinusitis
  • Eosinophils
  • nasal polyps

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Treatment of chronic rhinosinusitis with intranasal amphotericin B : A randomized, placebo-controlled, double-blind pilot trial. / Ponikau, Jens U.; Sherris, David A.; Weaver, Amy; Kita, Hirohito.

In: Journal of Allergy and Clinical Immunology, Vol. 115, No. 1, 01.2005, p. 125-131.

Research output: Contribution to journalArticle

@article{a8acf80a8f1741ac8a2d172acf37d0c8,
title = "Treatment of chronic rhinosinusitis with intranasal amphotericin B: A randomized, placebo-controlled, double-blind pilot trial",
abstract = "Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its etiology is unknown, and there is a paucity of effective medical treatments. 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. 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 μg/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. 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). 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.",
keywords = "amphotericin B, antifungal, chronic rhinosinusitis, chronic sinusitis, Eosinophils, nasal polyps",
author = "Ponikau, {Jens U.} and Sherris, {David A.} and Amy Weaver and Hirohito Kita",
year = "2005",
month = "1",
doi = "10.1016/j.jaci.2004.09.037",
language = "English (US)",
volume = "115",
pages = "125--131",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - Treatment of chronic rhinosinusitis with intranasal amphotericin B

T2 - A randomized, placebo-controlled, double-blind pilot trial

AU - Ponikau, Jens U.

AU - Sherris, David A.

AU - Weaver, Amy

AU - Kita, Hirohito

PY - 2005/1

Y1 - 2005/1

N2 - Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its etiology is unknown, and there is a paucity of effective medical treatments. 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. 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 μg/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. 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). 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.

AB - Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its etiology is unknown, and there is a paucity of effective medical treatments. 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. 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 μg/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. 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). 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.

KW - amphotericin B

KW - antifungal

KW - chronic rhinosinusitis

KW - chronic sinusitis

KW - Eosinophils

KW - nasal polyps

UR - http://www.scopus.com/inward/record.url?scp=11344264163&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=11344264163&partnerID=8YFLogxK

U2 - 10.1016/j.jaci.2004.09.037

DO - 10.1016/j.jaci.2004.09.037

M3 - Article

C2 - 15637558

AN - SCOPUS:11344264163

VL - 115

SP - 125

EP - 131

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

SN - 0091-6749

IS - 1

ER -