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RCT of Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02285283
Recruitment Status : Recruiting
First Posted : November 6, 2014
Last Update Posted : December 4, 2017
Information provided by (Responsible Party):
Amber Luong, 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).

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Drug: Itraconazole Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02285283

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Contact: Amber Luong, MD, PhD
Contact: Sana Sarfaraz

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United States, Texas
University of Texas Medical School at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Amber Luong, MD, PhD   
Contact: Sana Sarfaraz   
Principal Investigator: Amber Luong, MD, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston

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Responsible Party: Amber Luong, Associated Professor, The University of Texas Health Science Center, Houston Identifier: NCT02285283     History of Changes
Other Study ID Numbers: HSC-MS-14-0165
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
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Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
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