Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

Study Overview
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Brief Summary
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The purpose of this randomized controlled double-blinded trial is to determine if the addition of an oral antifungal to typical post-operative medical therapy can prevent or reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Detailed Description
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CRSwNP patients scheduled for medically-indicated sinus surgery will undergo screening ELIspot assay to identify patients with fungal sensitivity based on positive fungal induced interleukin 4 (IL-4) ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and randomized into either placebo or itraconazole 200 mg taken by mouth twice a day (PO BID) for 24 weeks in addition to standardized post-surgical regimen (9 days of perioperative prednisone, saline irrigations and pain medication as needed). Patients will be followed as outpatient in rhinology clinic for 48 weeks total. During these post-op visits, compliance with medications will be determined. Patients will be questioned about any possible side effects or adverse events to post-operative medications. Then, the patients will be evaluated by 2 nasal specific quality of life questionnaires and nasal endoscopy. The goals of the nasal endoscopy are to evaluate the state of the sinus mucosa and to determine recurrence of nasal polyps.

Official Title
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Randomized Double-Blinded Controlled Trial of Oral Antifungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Drug: Itraconazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery Exclusion Criteria: cystic fibrosis aspirin exacerbated respiratory disease uncontrolled or unstable chronic diseases such as uncontrolled diabetes active or history of cancer HIV positive history of liver or kidney disease history of disease with effects on immune system pregnant allergy to triazole antifungals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>2 capsules by mouth twice a day for 24 weeks | Drug: Placebo<br> <br> |
| Active Comparator: Itraconazole<br>Two 100mg capsules by mouth twice a day for 24 weeks | Drug: Itraconazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Recurrence of Nasal Polyps Requiring Intervention | Recurrence of nasal polyps requiring intervention | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo | Adverse events during time frame of taking medication/placebo | 24 weeks |