Concentration of Itraconazole Solution in Nasal Secretions

NCT00588016 | Completed Phase 1 DMC

• 1 other identifier: 06-009651
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

Itraconazole

Outcome Measures

Primary Outcomes (1)

• Concentration of Itraconazole in nasal secretions at 7 days

  7 days after initiation of study

Study Arms (1)

Itraconazole

EXPERIMENTAL

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

Interventions

Itraconazole DRUG

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

Also known as: Sporanox

Itraconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Hirohito Kita, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Study Start: April 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)