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临床试验/NCT02285283
NCT02285283终止2 期

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

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
58
试验地点
1
主要终点
Number of Participants With Recurrence of Nasal Polyps Requiring Intervention

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery

排除标准

  • 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
  • allergy to triazole antifungals

研究组 & 干预措施

Placebo

Placebo Comparator

2 capsules by mouth twice a day for 24 weeks

干预措施: Placebo (Drug)

Itraconazole

Active Comparator

Two 100mg capsules by mouth twice a day for 24 weeks

干预措施: Itraconazole (Drug)

结局指标

主要结局

Number of Participants With Recurrence of Nasal Polyps Requiring Intervention

时间窗: 48 weeks

Recurrence of nasal polyps requiring intervention

次要结局

  • Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amber Luong

Associated Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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