The primary objective of this study is to determine the concentration of itraconazole
irrigation in nasal mucous specimens via collection and High-performance liquid
chromatography (HPLC) assay.
Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be
enrolled in the initial evaluation. After an initial control nasal specimen, followed by
seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected
at varying time intervals and the concentrations measured.
The primary endpoint is development of a reliable collection and assay technique with
concentration curves over time of topically administered itraconazole. A secondary endpoint
is to determine if the concentrations measured achieve a mean inhibitory concentration
(MIC90) to commonly cultured fungal species in the nose.
This is a pilot study for the purpose of gathering concentration data on a commonly used
topical antifungal solution of itraconazole. CRS patients that meet the defined inclusion
criteria will begin topical itraconazole antifungal irrigations on Day 1. This will consist
of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of
solution twice daily, with a bulb syringe as directed. The patient will return on Day 7 for
repeat examination and nasal secretion collection. Two patients will be randomly selected
to have blood drawn at the completion of day 7 testing to determine the concentration of
itraconazole in the blood.
- Greater than or equal to eighteen years of age.
- Patient must be willing to be available and comply with all scheduled procedures as
defined in the protocol.
- Patients that have been felt to be candidates for topical itraconazole therapy and
would have been started on the therapy regardless of study inclusion
- CRS defined by American Academy of Otolaryngology - Head and Neck Surgery (AAO HNS)
- Do not meet CRS definitions. No acute sinusitis within past 4 weeks. No previous
surgery for rhinosinusitis. No history of allergic rhinitis or other rhinologic
- Previous use of a topical antifungal nasal irrigation within the past 2 weeks or a
systemic antifungal medication within the past 3 months.
- History of cystic fibrosis, immunodeficiency, immotile cilia syndrome, clinical or
radiographic suspicion for fungal mycetoma or invasive fungal sinusitis
- Pregnancy - female patients of child bearing age will undergo a pregnancy test, if
positive they will be excluded
- History of liver disease
- History of congestive heart failure
- Allergy or sensitivity to itraconazole, or other azole antifungals, or any other
ingredient in the preparation.