Official Title: “Concentration of Itraconazole Solution in Nasal Secretions”

The primary objective of this study is to determine the concentration of itraconazole irrigation in nasal mucous specimens via collection and 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.

Study Type: Interventional

Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: itraconazole
  • topical application to nose for chronic sinusitis BID X 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• The primary endpoint is development of a reliable collection and assay technique with concentration curves over time of topically administered itraconazole.
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• A secondary endpoint is to determine if the concentrations measured achieve a mean inhibitory concentration (MIC90) to commonly cultured fungal species in the nose.
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

General:

• 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

Medical:

• CRS defined by AAOHNS guidelines

Controls:

• 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 disorders.

Exclusion Criteria:

General:

• Previous use of a topical antifungal nasal irrigation within the past 2 weeks or a systemic antifungal medication within the past 3 months.

Medical:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mayo Clinic

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588016

Study ID Number: 06-009651

ClinicalTrials.gov Identifier: NCT00588016

Health Authority: United States: Food and Drug Administration

Mayo Clinic Clinical Trials