Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

The University of Texas System (UT)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Chronic Rhinosinusitis

Treatments: Drug: Placebo; Drug: Itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02285283

HSC-MS-14-0165

Details and patient eligibility

About

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).

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 capsules by mouth twice a day for 24 weeks

Treatment:

Drug: Placebo

Itraconazole

Active Comparator group

Description:

Two 100mg capsules by mouth twice a day for 24 weeks

Treatment:

Drug: Itraconazole