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

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Rhinosinusitis
• Intervention / Treatment: Drug: Placebo; Drug: Itraconazole

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Medical School at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 2 capsules by mouth twice a day for 24 weeks	Drug: Placebo
Active Comparator: Itraconazole; Two 100mg capsules by mouth twice a day for 24 weeks	Drug: Itraconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrence of Nasal Polyps Requiring Intervention	Recurrence of nasal polyps requiring intervention	48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Amber Luong, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Nasal Polyps; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: HSC-MS-14-0165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No