A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 519
- 试验地点
- 1
- 主要终点
- Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
研究概览
简要总结
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.
详细描述
This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent
- •Male or females ≥ 40 years of age
- •Established clinical history of COPD by ATS/ERS definition
- •Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
- •Former or current smoker > 10 pack years
- •Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)
排除标准
- •Current diagnosis of asthma
- •Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- •Lung volume reduction surgery within previous 12 months
- •Clinically significant abnormalities not due to COPD by chest x-ray
- •Hospitalized for poorly controlled COPD within 12 weeks of Screening
- •Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
- •Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
- •Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
- •Carcinoma not in complete remission for at least 5 years
- •Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
- •Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation
- •Known/suspected history of alcohol or drug abuse in the last 2 years
- •Women who are pregnant or lactating or plan to become pregnant
- •Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
- •Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
- •Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
- •Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
- •Non-compliance or inability to comply with study procedures or scheduled visits
- •Affiliation with investigator site
研究组 & 干预措施
Fluticasone Furoate / GW642444 (vilanterol)
Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
干预措施: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg (Drug)
Fluticasone Propionate / salmeterol
Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
干预措施: Fluticasone Propionate 250mcg/ salmeterol 50mcg (Drug)
结局指标
主要结局
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
时间窗: Baseline (Day 1) and Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
次要结局
- Time to Onset on Treatment Day 1(Day 1)