NCT01013701终止4 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center Study to Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.
研究概览
简要总结
Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients 18-70 years of age, in general good health.
- •Current evidence of nasal polyps on physical exam. 3) Able to understand the protocol and comply with instructions. 4) Have a negative urine pregnancy test in women of childbearing potential. 5) Women of childbearing potential must be on an acceptable method of birth control or willing to remain abstinent through the duration of the study.
排除标准
- •Are pregnant and/or breast-feeding.
- •History of alcohol or drug abuse in the past year.
- •Signs and symptoms suggestive of fulminant bacterial sinusitis (fever >101 F, persistent severe unilateral facial or tooth pain, facial swelling).
- •Allergies to nasal corticosteroids
- •.Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.
研究组 & 干预措施
Fluticasone Furoate
Active Comparator
nasal steroid
干预措施: fluticasone furoate (Drug)
Placebo
Placebo Comparator
nasal spray vehicle without drug
干预措施: placebo (Other)
结局指标
主要结局
To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.
时间窗: 18 weeks
次要结局
- To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.(18 weeks)
研究者
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