ACTRN12608000140358招募中2 期
A randomised controlled trial evaluating the safety and efficacy of Flutcasone Propionate Nasal Drops, Nasal Spray and Suspension for Nebulization in post-surgical participants with chronic sinusitis
aryx Pharma, Inc.0 个研究点目标入组 30 人开始时间: 2008年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Changes from baseline in weekly average sum scores for the subject rated sinus symptoms of nasal congestion, post-nasal drip, and one of the following symptoms (identified as the worst at Screening): facial or sinus pain, facial or sinus pressure, or sinus headache; during the fourth week of therapy
排除标准
- •1. Females who are either pregnant, breastfeeding or of child bearing potential not using adequate birth control.
- •2. Evidence of infection by purulent drainage from an open sinus cavity visualized by nasal endoscopy 3. Nasal polyposis causing obstruction of any open sinus cavity rending them inaccessaible to endoscopic exam 4. Known allergy or hypersensitivity of fluticasone propionate or any of the formulation components of the product. 5. any disease or condition requiring corticosteroid therapy 6.Any use of antibiotics or anti-fungals, decongestants and/or antihistamines within the past 7 days prior to randomization 7. Any condition that would make the administration of fluticasone propionate clinically inadvisable 8. Use of any systemic corticosteroids within the past 30 days prior to screening 9. Use of nasal or inhaled corticosteroids within the past 14 days prior to randomization 10. Use of mast cell or leukotriene inhibitors when necessary within the past 14 days prior to randomization
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