NCT00733005已完成3 期
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 主要终点
- The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.
研究概览
简要总结
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject must be 12 years of age or older, of either sex, and of any race.
- •A subject must have at least a 2-year history of SAR which exacerbates during the study season.
- •A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit
- •A subject must be clinically symptomatic at the Screening and Baseline Visits.
排除标准
- •A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- •A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- •A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- •A subject who is participating in any other clinical study.
- •A subject who is part of the staff personnel directly involved with this study.
- •A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
- •A female subject who is breast-feeding, pregnant, or intends to become pregnant.
- •A subject previously randomized into this study.
- •A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
研究组 & 干预措施
Arm 1
Experimental
Mometasone furoate nasal spray 200 mcg QD (once per day)
干预措施: Mometasone furoate nasal spray (MFNS) (Drug)
Arm 2
Placebo Comparator
Matching placebo nasal spray
干预措施: Matching placebo nasal spray (Drug)
结局指标
主要结局
The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.
时间窗: 15 days of treatment
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\])
次要结局
- The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days(15 days of treatment)
研究者
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