A Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Assess Efficacy and Safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 810
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
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
- 否
入选标准
- •Clinical diagnosis of asthma
- •Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
- •FEV1 of 40-85% predicted normal
- •Currently using inhaled corticosteroid therapy
排除标准
- •History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
- •Respiratory infection or oral candidiasis
- •Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
- •Uncontrolled disease or clinical abnormality
- •Allergies
- •Taking another investigational medication or prohibited medication
- •Night shift workers
- •Current smokers or subjects with smoking history of at least 10 pack years
研究组 & 干预措施
Fluticasone furoate/Vilanterol (GW642444)
Fluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks
干预措施: Fluticasone furoate/Vilanterol Inhalation Powder (Drug)
Fluticasone furoate/Vilanterol (GW642444)
Fluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks
干预措施: Placebo (2) (Drug)
Fluticasone propionate/salmeterol
Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks
干预措施: Fluticasone propionate/salmeterol Inhalation Powder (Drug)
Fluticasone propionate/salmeterol
Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks
干预措施: Placebo (1) (Drug)
结局指标
主要结局
Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24
时间窗: Baseline and Day 168/Week 24
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
次要结局
- Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1(Baseline to Day 1)
- Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168(Baseline and Day 168)
- Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1(Baseline and Day 168)
- Serial FEV1 (0-24 Hours)(Day 168)
- Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)(Baseline and Randomization)
- Change From Baseline in Trough FEV1 at Day 168(Baseline and Day 168)