NCT00425620已完成3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
Accentia Biopharmaceuticals68 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 68
- 主要终点
- The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
研究概览
简要总结
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of refractory, postsurgical chronic sinusitis
- •Has a documented history of chronic sinusitis symptoms for more than 12 weeks
- •A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus
- •An endoscopy documenting the presence of inflammation and absence of stage 4 polyps
- •Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months
- •Females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study.
- •Ability to read or speak English
排除标准
- •Has a hypersensitivity to Amphotericin B or the compounds of any study medications
- •Is an immunosuppressed patient or is receiving disease modifying agents
- •Has an acute upper or lower respiratory illness
- •Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization
- •Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization
- •Has used any antibiotic therapy for acute complication of chronic sinusitis within 1 month prior to randomization
- •Has orbital or central nervous system complications
- •Has acute asthma at study initiation
- •Began using nasal corticosteroids or had a dosage change within 3 months prior to randomization
- •Has taken a dose of oral or intravenous steroids to treat any condition other than asthma within 1 month prior to randomization
- •Has used any systemic antifungal therapy within 3 months prior to randomization
- •Has used intranasal antifungal therapy for chronic sinusitis within 3 months prior to randomization
- •Currently has a clinically significant deviated nasal septum that has not been remedied by surgery
- •Has an anatomical abnormality which would significantly obstruct the nasal passages
- •Has cystic fibrosis
- •Is pregnant
- •Has stage 4 polyposis
- •Has any significant medical condition that in a doctor's opinion could affect the patient's participation in the trial
- •Has used any investigational product within 1 month of study initiation
- •Has a history of cancer other than treated squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to study initiation
研究组 & 干预措施
Amphotericin B
Experimental
干预措施: SinuNase (Drug)
结局指标
主要结局
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
时间窗: Four months
次要结局
未报告次要终点
研究者
研究点 (68)
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