A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,020
- 试验地点
- 1
- 主要终点
- Number of Participants With 1 or More Severe Asthma Exacerbations
研究概览
简要总结
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
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
- Triple (Participant, Care Provider, 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 FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- •FEV1 of fifty to ninety percent of predicted
- •Currently using inhaled corticosteroid therapy
- •History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year
排除标准
- •History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
- •Respiratory infection or oral candidiasis
- •- Uncontrolled disease or clinical abnormality
- •Allergies
- •Taking another investigational medication or prohibited medication
研究组 & 干预措施
Fluticasone furoate/GW642444
干预措施: Fluticasone Furoate/GW642444 (Drug)
fluticasone furoate
干预措施: Fluticasone furoate (Drug)
结局指标
主要结局
Number of Participants With 1 or More Severe Asthma Exacerbations
时间窗: Baseline to Follow-up (up to 76 weeks of treatment)
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second \[FEV1, maximum amount of air forcefully exhaled in one second\]), sex, age, and region.
次要结局
- Number of Severe Asthma Exacerbations(Baseline to Follow-up (up to 76 weeks of treatment))
- Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36(Baseline and Week 36)