MedTrace Logo

Concentration of Itraconazole Solution in Nasal Secretions

NCT00588016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-04-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Hirohito Kita, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00588016 on ClinicalTrials.gov