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临床试验/NCT00118703
NCT00118703已完成3 期

A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis

GlaxoSmithKline60 个研究点 分布在 5 个国家目标入组 350 人开始时间: 2005年7月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
350
试验地点
60
主要终点
Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (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
盲法
Double (Participant, Investigator)

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

入选标准

  • Must be outpatients.
  • Diagnosis of VMR (vasomotor rhinitis).
  • Literate in English or native language.

排除标准

  • Significant concomitant medical condition.
  • Use corticosteroids or other allergy medications during the study.
  • Used tobacco products within the past year.

结局指标

主要结局

Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)

时间窗: Baseline and up to Week 4

The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). 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. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \[PM\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.

次要结局

  • Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)(Baseline and up to Week 4)
  • Number of Participants Based on Overall Evaluation of Response to Therapy(Week 4 (Day 29) or Early Withdrawal)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (60)

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