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

Journal of Allergy and Clinical Immunology

Volumn 115, Issue 1, 2005, Pages 125-131

  Ponikau, Jens U ^a   Sherris, David A ^b   Weaver, Amy ^a   Kita, Hirohito ^a  

^a MAYO CLINIC ROCHESTER   (United States)

^b UNIVERSITY AT BUFFALO   (United States)

Author keywords

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

Indexed keywords

AMPHOTERICIN B; ANTIFUNGAL AGENT; INTERLEUKIN 15; NEUROTOXIN; PLACEBO;

ADULT; AGED; ARTICLE; BURNING SENSATION; CHRONIC DISEASE; CHRONIC RHINOSINUSITIS; CLINICAL ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONCENTRATION (PARAMETERS); CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG INSTILLATION; ENDOSCOPY; EOSINOPHIL; FEMALE; HEALTH CENTER; HUMAN; MALE; NOSE CARTILAGE; NOSE DISEASE; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOSINUSITIS; SCORING SYSTEM; SIDE EFFECT; STANDARDIZATION;

ADMINISTRATION, INTRANASAL; ADULT; AGED; AMPHOTERICIN B; ANTIFUNGAL AGENTS; CHRONIC DISEASE; DOUBLE-BLIND METHOD; EOSINOPHILS; FEMALE; HUMANS; INTERLEUKIN-5; LYMPHOCYTE COUNT; MALE; MIDDLE AGED; MUCUS; NASAL MUCOSA; PILOT PROJECTS; RHINITIS; SINUSITIS;

EID: 11344264163     PISSN: 00916749     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jaci.2004.09.037     Document Type: Article

References (33)

1. M.A. Kaliner, J.D. Osguthorpe, P. Fireman, J. Anon, J. Georgitis, and M.L. Davis Sinusitis: bench to bedside: current findings, future directions Otolaryngol Head Neck Surg 116 1997 S1 S20
2. M.S. Benninger, B.J. Ferguson, J.A. Hadley, D.L. Hamilos, M. Jacobs, and D.W. Kennedy Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology Otolaryngol Head Neck Surg 129 2003 S1 S32
3. M. Lethbridge-Çejku, J.S. Schiller, and L. Bernadel Summary health statistics for U.S. adults: National Health Interview Survey, 2002. National Center for Health Statistics Vital Health Stat 10 2004 23
4. R.E. Gliklich, and R. Metson The health impact of chronic sinusitis in patients seeking otolaryngologic care Otolaryngol Head Neck Surg 113 1995 104 109
5. D.L. Hamilos, D.Y. Leung, R. Wood, A. Meyers, J.K. Stephens, and J. Barkans Chronic hyperplastic sinusitis: association of tissue eosinophilia with mRNA expression of granulocyte-macrophage colony-stimulating factor and interleukin-3 J Allergy Clin Immunol 92 1993 39 48
6. D.L. Hamilos Chronic sinusitis J Allergy Clin Immunol 106 2000 213 227
7. J.U. Ponikau, D.A. Sherris, G.M. Kephart, E.B. Kern, T.A. Gaffey, and J.E. Tarara Features of airway remodeling and eosinophilic inflammation in chronic rhinosinusitis: is the histopathology similar to asthma? J Allergy Clin Immunol 112 2003 877 882
8. S.L. Harlin, D.G. Ansel, J. Lane, J. Myers, T.M. Kephart, and G.J. Gleich A clinical and pathologic study of chronic sinusitis: the role of eosinophils J Allergy Clin Immunol 81 1988 867 875
9. J.U. Ponikau, D.A. Sherris, E.B. Kern, H.A. Homburger, E. Frigas, and T.A. Gaffey The diagnosis and incidence of allergic fungal sinusitis Mayo Clin Proc 74 1999 877 884
10. A.F. Lopez, C.J. Sanderson, J.R. Gamble, H.D. Campbell, I.G. Young, and M.A. Vadas Recombinant human interleukin 5 is a selective activator of human eosinophil function J Exp Med 167 1988 219 224
11. D.L. Hamilos, D.Y. Leung, D.P. Huston, A. Kamil, R. Wood, and Q. Hamid GM-CSF, IL-5 and RANTES immunoreactivity and mRNA expression in chronic hyperplastic sinusitis with nasal polyposis (NP) Clin Exp Allergy 28 1998 1145 1152
12. K. Hisamatsu, T. Ganbo, T. Nakazawa, Y. Murakami, G.J. Gleich, and K. Makiyama Cytotoxicity of human eosinophil granule major basic protein to human nasal sinus mucosa in vitro J Allergy Clin Immunol 86 1990 52 63
13. H. Braun, W. Buzina, K. Freudenschuss, A. Beham, and H. Stammberger "Eosinophilic fungal rhinosinusitis": a common disorder in Europe? Laryngoscope 113 2003 264 269
14. M.J. Taylor, J.U. Ponikau, D.A. Sherris, E.B. Kern, T.A. Gaffey, and G. Kephart Detection of fungal organisms in eosinophilic mucin using a fluorescein-labeled chitin-specific binding protein Otolaryngol Head Neck Surg 127 2002 377 383
15. J.U. Ponikau, D.A. Sherris, H. Kita, and E.B. Kern Intranasal antifungal treatment in 51 patients with chronic rhinosinusitis J Allergy Clin Immunol 110 2002 862 866
16. A. Ricchetti, B.N. Landis, A. Maffioli, R. Giger, C. Zeng, and J.S. Lacroix Effect of anti-fungal nasal lavage with amphotericin B on nasal polyposis J Laryngol Otol 116 2002 261 263
17. M. Weschta, D. Rimek, M. Formanek, D. Polzehl, A. Podbielski, and H. Riechelmann Topical antifungal treatment of chronic rhinosinusitis with nasal polyps: a randomized, double-blind clinical trial J Allergy Clin Immunol 113 2004 1122 1128
18. J.F. Piccirillo, M.G. Merritt Jr., and M.L. Richards Psychometric and clinimetric validity of the 20-item Sino-Nasal Outcome Test (SNOT-20) Otolaryngol Head Neck Surg 126 2002 41 47
19. R.I. Abu-Ghazaleh, S.L. Dunnette, D.A. Loegering, J.L. Checkel, H. Kita, and L.L. Thomas Eosinophil granule proteins in peripheral blood granulocytes J Leukocyte Biol 52 1992 611 618
20. H. Kita, R.K. Jorgensen, C.E. Reed, S.L. Dunnette, M.C. Swanson, and K.R. Bartemes Mechanism of topical glucocorticoid treatment of hay fever: IL-5 and eosinophil activation during natural allergen exposure are suppressed, but IL-4, IL-6, and IgE antibody production are unaffected J Allergy Clin Immunol 106 2000 521 529
21. M.C. Swanson, M.E. Bubak, L.W. Hunt, J.W. Yunginger, M.A. Warner, and C.E. Reed Quantification of occupational latex aeroallergens in a medical center J Allergy Clin Immunol 94 1994 445 451
22. A.J. Vickers, and D.G. Altman Statistic notes: analysing controlled trials with baseline and follow up measurements BMJ 323 2001 1123 1124
23. Drug shortages. U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 2003. Available at: http://www.fda.gov/cder/drug/ shortages/default.htm. Accessed June 12, 2003.
24. Companies announce shortage of anti-fungal drug Drug Industry Daily 2 115 2003 5
25. T.J. Kenny, J. Duncavage, J. Bracikowski, A. Yildirim, J.J. Murray, and S.B. Tanner Prospective analysis of sinus symptoms and correlation with paranasal computed tomography scan Otolaryngol Head Neck Surg 125 2001 40 43
26. J.F. Gallelli Assay and stability of amphotericin B in aqueous solutions Drug Intell Clin Pharm 1 1967 102
27. S.C. Cheung, G. Medoff, D. Schlessinger, and G.S. Kobayashi Stability of amphotericin B in fungal culture media Antimicrob Agents Chemother 8 1975 426 428
28. S.-H. Shin, J.U. Ponikau, D.A. Sherris, D. Congdon, E. Frigas, and H.A. Homburger Chronic rhinosinusitis: an enhanced immune response to ubiquitous airborne fungi J Allergy Clin Immunol 114 2004 1369 1375
29. H. Kita, C.R. Adolphson, and G.J. Gleich Biology of eosinophils N.F. Adkinson Jr. B.S. Bochner J.W. Yunginger S.T. Holgate W.W. Busse F.E. Simons Middleton's allergy principles & practice 6th ed. 2003 Mosby Philadelphia 305 332
30. H.U. Simon, S. Yousefi, C. Schranz, A. Schapowal, C. Bachert, and K. Blaser Direct demonstration of delayed eosinophil apoptosis as a mechanism causing tissue eosinophilia J Immunol 158 1997 3902 3908
31. M.M. Lowery, and P.A. Greenberger Amphotericin-induced stridor: a review of stridor, amphotericin preparations, and their immunoregulatory effects Ann Allergy Asthma Immunol 91 2003 460 466
32. J.E. Bennett Antimicrobial agents: antifungal agents J.G. Hardman L.E. Limbird Goodman & Gilman's the pharmacological basis of therapeutics 9th ed. 1996 McGraw-Hill New York 1175 1190
33. Product information: Fungizone(R) 1994 ER Squibb & Sons Inc Princeton, NJ p. 1