A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 3
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
研究概览
简要总结
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines
- •Patients who have smoking history of at least 10 pack years.
- •Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.
排除标准
- •Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
- •Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
- •Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- •Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
- •Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm
- •Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
- •Patients with uncontrolled Type I and Type II diabetes.
- •History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
- •Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
- •Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
- •Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
placebo
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
干预措施: placebo (Drug)
indacaterol/glycopyrrolate 300/50 μg
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
干预措施: indacaterol/glycopyrrolate (Drug)
indacaterol 600 μg
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
干预措施: indacaterol (Drug)
indacaterol 300 μg
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
干预措施: indacaterol (Drug)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
时间窗: Baseline, Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
次要结局
- Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events(47 days)
- Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7(Day 7)