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RCT of Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Amber Luong, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02285283
First received: November 4, 2014
Last updated: October 24, 2016
Last verified: October 2016
  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 Intervention Phase
Chronic Rhinosinusitis
Drug: Itraconazole
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blinded Controlled Trial of Oral Antifungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Recurrence of nasal polyps [ Time Frame: 48 weeks ]
    Recurrence of nasal polyps requiring intervention


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 24 weeks ]
    Adverse events during time frame of taking medication/placebo


Estimated Enrollment: 340
Study Start Date: November 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 IL-4 ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and randomized into either placebo or itraconazole 200 mg 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02285283

Contacts
Contact: Amber Luong, MD, PhD amber.u.luong@uth.tmc.edu
Contact: Sana Sarfaraz sana.sarfaraz@uth.tmc.edu

Locations
United States, Texas
University of Texas Medical School at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Amber Luong, MD, PhD       amber.u.luong@uth.tmc.edu   
Contact: Sana Sarfaraz       sana.sarfaraz@uth.tmc.edu   
Principal Investigator: Amber Luong, MD, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Amber Luong, Associated Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02285283     History of Changes
Other Study ID Numbers: HSC-MS-14-0165
Study First Received: November 4, 2014
Last Updated: October 24, 2016

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors

ClinicalTrials.gov processed this record on May 23, 2017