EUCTR2011-001368-23-Outside-EU/EEA进行中（未招募）不适用
Active-Controlled Trial of the Safety and Tolerability of MP29-02 in Subjects with Chronic Allergic or Nonallergic Rhinitis
适应症
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
- •Patients with established history (= 1 year) of rhinitis due to perennial allergies or non-allergic rhinitis (VMR)
- •General good health and lack of any disease or concomitant treatment that could have interfered with the interpretation of the study results
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 569
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Presence on nasal examination of any nasal ulceration (grade 3) or nasal septal perforation (grade 4) 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
- •Patients with a fasting morning plasma cortisol level less than or equal to 5 µg/dL (or 150 nmol/L) for patients participating in the HPA axis sub-study
- •Patients receiving immunotherapy injections and not on stable maintenance regimen for at least 30 days before the first study visit
- •Use of systemic corticosteroid, omalizumab or inhaled corticosteroids / inhaled corticosteroid in combination 30 days prior to screening
研究者
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