Concentration of Itraconazole Solution in Nasal Secretions

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

John F. Pallanch, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00588016

First received: December 26, 2007

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 26, 2007
Last Updated Date	June 6, 2012
Start Date ^ICMJE	April 2007
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 7, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00588016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 7, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Concentration of Itraconazole Solution in Nasal Secretions
Official Title ^ICMJE	Concentration of Itraconazole Solution in Nasal Secretions
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Nasal Secretions
Intervention ^ICMJE	Drug: itraconazole topical application to nose for chronic sinusitis BID X 7 days
Study Arm (s)	Experimental: 1 Intervention: Drug: itraconazole
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	December 2013
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00588016
Other Study ID Numbers ^ICMJE	06-009651
Has Data Monitoring Committee	Yes
Responsible Party	John F. Pallanch, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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