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
  Purpose

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.


Condition Intervention Phase
Sinusitis
Drug: Itraconazole
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Concentration of Itraconazole in nasal secretions at 7 days [ Time Frame: 7 days after initiation of study ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: April 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Hirohito Kita, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Hirohito Kita, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588016     History of Changes
Other Study ID Numbers: 06-009651
Study First Received: December 26, 2007
Last Updated: April 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Itraconazole

Additional relevant MeSH terms:
Hydroxyitraconazole
Itraconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 19, 2015