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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
  Purpose

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.


Condition Intervention
Nasal Secretions
Drug: itraconazole

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: April 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: itraconazole
topical application to nose for chronic sinusitis BID X 7 days

  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 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.
  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
  More Information

Additional Information:
No publications provided

Responsible Party: John F. Pallanch, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588016     History of Changes
Other Study ID Numbers: 06-009651
Study First Received: December 26, 2007
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
focus of study is measuring itraconazole in nasal mucin

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 November 25, 2014