Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
Purpose
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).
Condition
- Chronic Rhinosinusitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
2 capsules by mouth twice a day for 24 weeks |
|
|
Active Comparator Itraconazole |
Two 100mg capsules by mouth twice a day for 24 weeks |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Health Science Center, Houston
Study Contact
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.