NCT02285283

Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Itraconazole
DRUG	Placebo

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2014-11-06
• Last updated: 2020-10-28
• Results posted: 2020-10-28

Locations

1 site across 1 country: United States