Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

Phase 2

Terminated

• Conditions: Chronic Rhinosinusitis
• Interventions: Drug: Itraconazole; Drug: Placebo

• Registration Number: NCT02285283
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-06
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2020-10
• Results First Submitted: 2020-10-08
• Results First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-10-28
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itraconazole	Itraconazole	Two 100mg capsules by mouth twice a day for 24 weeks
Placebo	Placebo	2 capsules by mouth twice a day for 24 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Recurrence of Nasal Polyps Requiring Intervention	48 weeks	Recurrence of nasal polyps requiring intervention

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo	24 weeks	Adverse events during time frame of taking medication/placebo

Trial Locations

Locations (1)

University of Texas Medical School at Houston; 🇺🇸 Houston, Texas, United States