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 13, 2013
Last verified: June 2013

December 26, 2007
June 13, 2013
April 2007
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00588016 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Concentration of Itraconazole Solution in Nasal Secretions
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Nasal Secretions
Drug: itraconazole
topical application to nose for chronic sinusitis BID X 7 days
Experimental: 1
Intervention: Drug: itraconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588016
06-009651
Yes
John F. Pallanch, Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP