Concentration of Itraconazole Solution in Nasal Secretions

Condition(s) targeted: Nasal Secretions

Intervention: itraconazole (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Mayo Clinic

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.

Official title: Concentration of Itraconazole Solution in Nasal Secretions

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

Primary outcome: The primary endpoint is development of a reliable collection and assay technique with concentration curves over time of topically administered itraconazole.

Secondary outcome: A secondary endpoint is to determine if the concentrations measured achieve a mean inhibitory concentration (MIC90) to commonly cultured fungal species in the nose.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Mayo Clinic Clinical Trials

Starting date: April 2007
Ending date: July 2008
Last updated: January 7, 2008