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Concentration of Itraconazole Solution in Nasal Secretions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00588016
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Sinusitis Drug: Itraconazole Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concentration of Itraconazole Solution in Nasal Secretions
Study Start Date : April 2007
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Concentration of Itraconazole in nasal secretions at 7 days [ Time Frame: 7 days after initiation of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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


  • CRS defined by American Academy of Otolaryngology - Head and Neck Surgery (AAO HNS) guidelines


  • 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:


  • Previous use of a topical antifungal nasal irrigation within the past 2 weeks or a systemic antifungal medication within the past 3 months.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588016

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Hirohito Kita, MD Mayo Clinic
More Information

Responsible Party: Hirohito Kita, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588016     History of Changes
Other Study ID Numbers: 06-009651
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Hirohito Kita, Mayo Clinic:

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors