A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Number of Participants With Adverse Events and Adverse Drug Reactions
研究概览
简要总结
Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
- •Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
- •Male or female outpatients aged 3 to 15 years at the time of providing informed consent.
排除标准
- •Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
- •Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
- •Subjects with repeated epistaxis
- •Subjects with coexisting fungal infection in nasal/sinus cavity
- •Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
- •Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
- •Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
研究组 & 干预措施
MFNS 50 μg device
MFNS 50 μg spray device. The dose will be as follows:
- 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
- 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
干预措施: mometasone furoate (Drug)
结局指标
主要结局
Number of Participants With Adverse Events and Adverse Drug Reactions
时间窗: Baseline to Week 24
次要结局
- Change From Baseline in the Total Nasal Symptom Score(Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation))