A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
研究概览
简要总结
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male or female adults aged ≥40 yrs
- •Smoking history of at least 10 pack years
- •Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
- •Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- •Modified Medical Research Council questionnaire grade of 2 or higher
排除标准
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- •Patients with concomitant pulmonary disease
- •Patients with a history of asthma
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular co-morbid conditions
- •Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- •Patients in the active phase of a supervised pulmonary rehabilitation program
- •Patients contraindicated for inhaled anticholinergic agents and β2 agonists
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
First QVA149, then Umeclidinium/vilanterol
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
干预措施: QVA149 (Drug)
First QVA149, then Umeclidinium/vilanterol
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
干预措施: Umeclidinium/vilanterol (Drug)
First QVA149, then Umeclidinium/vilanterol
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
干预措施: Placebo (umeclidinium/vilanterol) (Drug)
First QVA149, then Umeclidinium/vilanterol
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
干预措施: Placebo (QVA149) (Drug)
First Umeclidinium/vilanterol, then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
干预措施: QVA149 (Drug)
First Umeclidinium/vilanterol, then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
干预措施: Umeclidinium/vilanterol (Drug)
First Umeclidinium/vilanterol, then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
干预措施: Placebo (umeclidinium/vilanterol) (Drug)
First Umeclidinium/vilanterol, then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
干预措施: Placebo (QVA149) (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
时间窗: baseline, 0 to 24 hours post-dose at week 12
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
次要结局
- Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h(baseline, 0 to 24 hours post-dose at week 12)
- Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)(baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12)
- Change From Baseline in FEV1 AUC 12-24h(baseline, 12 hours to 24 hours post-dose at week 12)
- Change From Baseline in FEV1 AUC 0-12h(baseline, 0 to 12 hours post-dose at week 12)
- Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h(baseline, 12 weeks)
- QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point(Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min))
- Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)(baseline, 15 minutes and 45 minutes pre morning dose at week 12)
- QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point(Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min))