Concentration of Itraconazole Solution in Nasal Secretions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hirohito Kita, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588016
First received: December 26, 2007
Last updated: April 12, 2015
Last verified: April 2015

December 26, 2007
April 12, 2015
April 2007
December 2013   (final data collection date for primary outcome measure)
Concentration of Itraconazole in nasal secretions at 7 days [ Time Frame: 7 days after initiation of study ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00588016 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
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 High-performance liquid chromatography (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.

This is a pilot study for the purpose of gathering concentration data on a commonly used topical antifungal solution of itraconazole. CRS patients that meet the defined inclusion criteria will begin topical itraconazole antifungal irrigations on Day 1. This will consist of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily, with a bulb syringe as directed. The patient will return on Day 7 for repeat examination and nasal secretion collection. Two patients will be randomly selected to have blood drawn at the completion of day 7 testing to determine the concentration of itraconazole in the blood.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sinusitis
Drug: Itraconazole
Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.
Other Name: Sporanox
Experimental: Itraconazole
Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.
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.
 
Completed
6
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 American Academy of Otolaryngology - Head and Neck Surgery (AAO HNS) 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
Hirohito Kita, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Hirohito Kita, MD Mayo Clinic
Mayo Clinic
April 2015

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