A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GW685698X
GW685698X
干预措施: GW685698X (Drug)
结局指标
主要结局
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
时间窗: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
次要结局
- Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Number of Participants With Overall Evaluation of Response to Therapy(Up to 4 weeks)
- Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)
- Mean Scores Changes From Baseline as a Function of Time(Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days)
- Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip(Baseline (4 days prior to randomization [Day 1]) and up to Week 4)