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Concentration of Itraconazole Solution in Nasal Secretions

Primary Purpose

Sinusitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Itraconazole

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring Itraconazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Itraconazole

Arm Description

Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.

Outcomes

Primary Outcome Measures

Concentration of Itraconazole in nasal secretions at 7 days

Secondary Outcome Measures

Full Information

NCT ID

NCT00588016

First Posted

December 26, 2007

Last Updated

April 12, 2015

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00588016

Brief Title

Concentration of Itraconazole Solution in Nasal Secretions

Official Title

Concentration of Itraconazole Solution in Nasal Secretions

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sinusitis

Keywords

Itraconazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Itraconazole

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Itraconazole

Other Intervention Name(s)

Sporanox

Intervention Description

Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.

Primary Outcome Measure Information:

Title

Concentration of Itraconazole in nasal secretions at 7 days

Time Frame

7 days after initiation of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hirohito Kita, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

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Concentration of Itraconazole Solution in Nasal Secretions

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