Concentration of Itraconazole Solution in Nasal Secretions
This study is enrolling participants by invitation only.
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
John F. Pallanch, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588016
First received: December 26, 2007
Last updated: June 6, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | September 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 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 6, 2012 |
| 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:
|
Itraconazole Hydroxyitraconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013