A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol 100/25mcg Versus Fluticasone Furoate 100mcg on Asthma Control in Patients With Uncontrolled Asthma
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of subjects with an improvement in ACQ-7 score of >= 0.5 at Week 12 compared to Baseline
研究概览
简要总结
The objective of this study is to evaluate fluticasone furoate/vilanterol compared with fluticasone furoate alone in subjects with asthma that is uncontrolled on low to mid dose inhaled corticosteroid (ICS) or low dose ICS/ long acting beta agonist (LABA) combination. This is a phase IV, randomized, double-blind, parallel group, multicenter study evaluating fluticasone furoate/vilanterol 100/25 micrograms (mcg) and fluticasone furoate 100 mcg once daily, delivered as an inhalation powder using the ELLIPTA® device in subjects with uncontrolled asthma despite daily ICS or ICS/LABA therapy. The study will measure treatment response and asthma control using the Asthma Control Questionnaire-7 (ACQ-7) focusing on symptomatic control. In this study, proportion of subjects with an improvement in ACQ-7 score of >=0.5 at Week 12 compared to Baseline for the fluticasone furoate/vilanterol 100 mcg/25 mcg and fluticasone furoate100 mcg groups will be assessed. The total study duration for each subject will be 17 weeks including 4-week run in period, 12-week treatment period and 1-week follow up period. Approximately 1012 subjects will be randomized into the study. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
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
- 18 Years 至 —（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
Subjects received Fluticasone Furoate/Vilanterol
Subjects will receive fluticasone furoate/vilanterol 100/25 mcg inhalation powder via ELLIPTA dry powder inhaler (DPI) once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
干预措施: Fluticasone Furoate/Vilanterol (Drug)
Subjects received Fluticasone Furoate/Vilanterol
Subjects will receive fluticasone furoate/vilanterol 100/25 mcg inhalation powder via ELLIPTA dry powder inhaler (DPI) once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
干预措施: Salbutamol/Albuterol (Drug)
Subjects received Fluticasone Furoate
Subjects will receive fluticasone furoate 100 mcg inhalation powder via ELLIPTA DPI once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
干预措施: Fluticasone Furoate (Drug)
Subjects received Fluticasone Furoate
Subjects will receive fluticasone furoate 100 mcg inhalation powder via ELLIPTA DPI once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
干预措施: Salbutamol/Albuterol (Drug)
结局指标
主要结局
Number of subjects with an improvement in ACQ-7 score of >= 0.5 at Week 12 compared to Baseline
时间窗: Baseline and at Week 12
The ACQ-7 consists of five questions about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) in the previous week, along with one question on daily bronchodilator use in the previous week, and a measure of lung function (forced expiratory volume in 1 second \[FEV1\] % predicted). The response options for all these questions consist of a zero (no impairment) to six (total impairment) scale. The questions are equally weighted, and the ACQ-7 score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A score \>= 1.5 indicates asthma that is not well controlled, while a mean score of \<= 0.75 indicates asthma that is well controlled, with a change of 0.5 defined as the minimal clinically important difference.
次要结局
- Change from Baseline in the percentage of symptom-free night time periods during the 12-week treatment period(Baseline and up to Week 12)
- Change from Baseline in the percentage of rescue-free daytime periods during the 12-week treatment period(Baseline and up to Week 12)
- Change from Baseline in the percentage of symptom-free daytime periods during the 12-week treatment period(Baseline and up to Week 12)
- Number of subjects with an ACQ-7 score <= 0.75 at Week 12(Baseline and at Week 12)
- Change from Baseline in the percentage of rescue-free night time periods during the 12-week treatment period(Baseline and up to Week 12)