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). CONCLUSION: 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.
RCT Entities:
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). CONCLUSION: 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: Joel M Bernstein; Stephen P Brooks; Heather K Lehman; Liza Pope; Amy Sands; Leonard D Shultz; Richard B Bankert Journal: Ann Otol Rhinol Laryngol Date: 2009-12 Impact factor: 1.547
Authors: Eli O Meltzer; Daniel L Hamilos; James A Hadley; Donald C Lanza; Bradley F Marple; Richard A Nicklas; Claus Bachert; James Baraniuk; Fuad M Baroody; Michael S Benninger; Itzhak Brook; Badrul A Chowdhury; Howard M Druce; Stephen Durham; Berrylin Ferguson; Jack M Gwaltney; Michael Kaliner; David W Kennedy; Valerie Lund; Robert Naclerio; Ruby Pawankar; Jay F Piccirillo; Patricia Rohane; Ronald Simon; Raymond G Slavin; Alkis Togias; Ellen R Wald; S James Zinreich Journal: Otolaryngol Head Neck Surg Date: 2004-12 Impact factor: 3.497
Authors: Eli O Meltzer; Daniel L Hamilos; James A Hadley; Donald C Lanza; Bradley F Marple; Richard A Nicklas; Claus Bachert; James Baraniuk; Fuad M Baroody; Michael S Benninger; Itzhak Brook; Badrul A Chowdhury; Howard M Druce; Stephen Durham; Berrylin Ferguson; Jack M Gwaltney; Michael Kaliner; David W Kennedy; Valerie Lund; Robert Naclerio; Ruby Pawankar; Jay F Piccirillo; Patricia Rohane; Ronald Simon; Raymond G Slavin; Alkis Togias; Ellen R Wald; S James Zinreich Journal: J Allergy Clin Immunol Date: 2004-12 Impact factor: 10.793