EUCTR2011-001314-34-Outside-EU/EEA进行中（未招募）不适用
Randomized, Double-Blind Trial of MP29-02 Nasal SprayCompared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Subjects with Seasonal Allergic Rhinitis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •12-hour reflective Total Nasal Symptom Score (TNSS) of at least 8 out of a possible 12 on screening visit, and a congestion score of 2 or 3 on Day -7
- •12-hour reflective TNSS of at least 8 on 3 separate symptom assessments during the lead-in period
- •12-hour reflective nasal congestion score of 2 or 3 recorded on 3 separate symptom assessments during the lead-in period
- •At least 2-year history of SAR during Texas Mountain Cedar season
- •Presence of IgE-mediated hypersensitivity to a Texas Mountain Cedar, confirmed by a positive response to skin prick within the last year
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 43
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 536
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Presence on nasal examination of any mucosal erosion, nasal ulceration, or nasal septal perforation on screening visit or randomisation visit
- •Nasal surgery or sinus surgery within the previous year
- •Chronic sinusitis with more than 3 episodes per year
- •Patients currently or during the previous 6-months on sublingual immunotherapy
- •Female adolescents who were pregnant or nursing
- •Patients receiving immunotherapy injections and not on stable maintenance regimen for at least 30 days before the first study visit
研究者
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