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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588016 |
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 |
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Nasal Secretions |
Drug: itraconazole |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Concentration of Itraconazole Solution in Nasal Secretions |
Estimated Enrollment: | 10 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: itraconazole
topical application to nose for chronic sinusitis BID X 7 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
General:
Medical:
Controls:
Exclusion Criteria:
General:
Medical:
Responsible Party: | Mayo Clinic ( Patrick Munson, MD ) |
Study ID Numbers: | 06-009651 |
Study First Received: | December 26, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00588016 History of Changes |
Health Authority: | United States: Food and Drug Administration |
focus of study is measuring itraconazole in nasal mucin |
Clotrimazole Miconazole Antifungal Agents |
Tioconazole Hydroxyitraconazole Itraconazole |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Therapeutic Uses |
Antifungal Agents Hydroxyitraconazole Itraconazole Pharmacologic Actions |