Randomized Double-Blinded Controlled Trial of Oral Antifungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
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
- 否
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
2 capsules by mouth twice a day for 24 weeks
干预措施: Placebo (Drug)
Itraconazole
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
Amber Luong
Associated Professor
The University of Texas Health Science Center, Houston
