EUCTR2011-001371-39-Outside-EU/EEA进行中（未招募）不适用
Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray and Fluticasone Propionate Nasal Spray in the Treatment of Patients with Seasonal Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
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
- •Patients with moderate-to-severe rhinitis
- •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 visit 1
- •12-hour reflective TNSS of at least 56 on 7 consecutive reflective AM and PM TNSS assessments 3 days prior to randomisation and morning of randomisation
- •12-hour reflective nasal congestion score of at least 14 recorded on 7 consecutive reflective AM and PM TNSS assessments 3 days prior to randomisation and morning of randomisation
- •Instantaneous TNSS of 8 or more at time point zero
- •At least 2-year history of SAR during current allergy season
- •Presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal pollen, 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: 197
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1549
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Presence on nasal examination of any superficial and moderate 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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