Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02285283
• Other study ID #: HSC-MS-14-0165
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: November 2014
• Est. completion date: May 15, 2019

Study information

• Verified date: October 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• Itraconazole

• Placebo

Locations

Country	Name	City	State
United States	University of Texas Medical School at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Recurrence of Nasal Polyps Requiring Intervention	Recurrence of nasal polyps requiring intervention	48 weeks
Secondary	Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo	Adverse events during time frame of taking medication/placebo	24 weeks