Concentration of Itraconazole Solution in Nasal Secretions - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588016

Purpose

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.

Condition	Intervention
Nasal Secretions	Drug: itraconazole

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Concentration of Itraconazole Solution in Nasal Secretions

Resource links provided by NLM:

Drug Information available for: Itraconazole

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: itraconazole topical application to nose for chronic sinusitis BID X 7 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588016

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	John Pallanch, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588016 History of Changes
Other Study ID Numbers:	06-009651
Study First Received:	December 26, 2007
Last Updated:	February 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

focus of study is measuring itraconazole in nasal mucin

Additional relevant MeSH terms:

Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012