A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
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 perennial allergic rhinitis (PAR).
详细描述
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)
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
- •Diagnosis of perennial allergic rhinitis (PAR).
- •Must comply with study procedures and be literate.
排除标准
- •Significant concomitant medical conditions.
- •Use of corticosteroids.
- •Use of allergy and other identified medications during the study.
- •Current tobacco use or tobacco use within the past year.
- •Exposure to an investigational study drug within the past 12 months.
- •Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
研究组 & 干预措施
Fluticasone furoate
Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg
干预措施: FF (Drug)
Placebo
Participants were instructed to administer two sprays into each nostril once daily every morning of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
时间窗: Baseline (Day 1) and up to Week 6
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received \>=1 dose of study drug. Only those participants available at the specified time points were analyzed
次要结局
- Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period(Baseline (Day 1) and up to Week 6)
- Number of Participants With Response to Therapy Over Entire Treatment Period(Up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period(Baseline and up to 6 weeks)
- Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)
- Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period(Baseline (Day 1) and up to 6 weeks)