Topical administration of a dilute solution of amphotericin B or other antifungal medication has been shown to reduce airway inflammation and thickening of the swollen mucosa(View Image). (1, 2, 3) This therapy's efficacy is due to the ability of the antifungals to control the population of fungus in the nasal cavity and mucus, and therefore reduce or prevent the production of antigens that induce the immune-mediated response in CRS patients. Similar results have been demonstrated with itraconazole and voriconazole.

An overview of these clinical studies is provided below. Health care providers are encouraged to bookmark this page and return frequently for updated information on the results of ongoing clinical studies.

Clinical Studies

• Intranasal antifungal treatment in 51 patients with chronic rhinosinusitis
  This open-label, prospective clinical trial demonstrated the safety and efficacy of treatment with the topical antifungal, amphotericin B. Twice daily intranasal application of a 100 mcg/ml solution resulted in symptom improvement and a reduction in airway inflammation assessed by endoscopic evaluation and/or CT scan. Patients received topical amphotericin B for 3 to 17 months (average of 11.3 months). Following a three-month or longer treatment course, improvement in sinus symptoms was demonstrated in 38 of 51 patients (75%). Endoscopic evaluation found 18 of 51 patients (35%) were free from disease following treatment and an additional 20 patients (39%) had improvement of at least one stage. CT scans were available for 13 patients and demonstrated significant reduction in nasal mucosal thickening and occlusion of the paranasal sinuses. Among those patients receiving systemic corticosteroids prior to the study, 80% of patients were able to stop or decrease use of that therapy.
  
  
• Effect of anti-fungal nasal lavage with amphotericin B on nasal polyposis
  In this study with 74 patients, four weeks of twice daily intranasal application of an amphotericin B solution (100 mcg/ml) resulted in reduction in nasal polyposis. Approximately 70% of patients demonstrated improvement. Prior to treatment, the number of patients with stage I, II, and III polyposis was 13, 48, and 13, respectively. Following four weeks of treatment, the number of patients with stage I, II and III disease was 8, 21 and 0, respectively and 47% of patients had complete disappearance of nasal polyposis.
  
  
• Treatment of chronic rhinosinusitis with intranasal amphotericin B.
  This prospective, randomized, placebo-controlled, double-blind study demonstrated that amphotericin B was effective in decreasing mucosal thickening. The primary outcome measure, reduction in occlusion measured by CT scan, was statistically significant at six months when compared to placebo-treated patients (View Graph). Endoscopy scores demonstrated statistically significant improvement at three and six months when compared to placebo. Eosinophil-derived neurotoxin (EDN, a marker for eosinophilia) and other markers of inflammation, including IL-5, were decreased in the mucus of patients treated with the topical antifungal therapy. For more information, the complete citation for this study is: Sherris DA, Ponikau JU, Weaver A, et al. Treatment of chronic rhinosinusitis with intranasal amphotericin B: A prospective, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2005;115:125-31. [Click here to download this article for viewing.] (A DocuRights® Service )

References

1. Ponikau JU, Sherris DA, Kita H, et al. Intranasal antifungal treatment in 51 patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2002;110:862-6.
   
   
2. Ricchetti A, Landis BN, Maffioli A, et al. Effect of anti-fungal nasal lavage with amphotericin B on nasal polyposis. J Laryngol Otol. 2002;116(4):261-3.
   
   
3. Sherris DA, Ponikau JU, Weaver A, et al. Treatment of chronic rhinosinusitis with intranasal amphotericin B: A prospective, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2005;115:125-31.