RCT of Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
| Status: | Recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/6/2017 |
| Start Date: | November 2014 |
| End Date: | December 2019 |
| Contact: | Amber Luong, MD, PhD |
| Email: | amber.u.luong@uth.tmc.edu |
Randomized Double-Blinded Controlled Trial of Oral Antifungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
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).
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).
CRSwNP patients scheduled for medically-indicated sinus surgery will undergo screening
ELIspot assay to identify patients with fungal sensitivity based on positive fungal induced
IL-4 ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and
randomized into either placebo or itraconazole 200 mg 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.
ELIspot assay to identify patients with fungal sensitivity based on positive fungal induced
IL-4 ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and
randomized into either placebo or itraconazole 200 mg 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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Amber Luong, MD, PhD
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