A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 257
- 试验地点
- 3
- 主要终点
- Change From Baseline in Mean 24 Hour Heart Rate at Day 14
研究概览
简要总结
An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.
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
- •Consented male or female adults aged ≥40 years
- •Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
- •Patients who have smoking history of at least 10 pack years
- •Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30% and <80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity (FVC) <0.70 at Visit 1 and Visit 3
排除标准
- •Pregnant or nursing (lactating) women
- •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 room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
- •Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
- •Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
- •Any history of asthma
- •Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
- •Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
- •Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)
- •History of malignancy of any organ system, treated or untreated within the past 5 years
- •Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) >8.0% of total hemoglobin measured at Visit 1
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
indacaterol/glycopyrrolate 600/100 μg
Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: indacaterol/glycopyrrolate (Drug)
indacaterol/glycopyrrolate 300/100 μg
One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: indacaterol/glycopyrrolate (Drug)
indacaterol/glycopyrrolate 300/100 μg
One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: placebo (Drug)
indacaterol/glycopyrrolate 150/100 μg
One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: indacaterol/glycopyrrolate (Drug)
indacaterol/glycopyrrolate 150/100 μg
One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: glycopyrrolate (Drug)
indacaterol 300 μg
One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: indacaterol (Drug)
indacaterol 300 μg
One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: placebo (Drug)
placebo
Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean 24 Hour Heart Rate at Day 14
时间窗: Baseline, Day 14
Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.
次要结局
- Change From Baseline in Mean 24 Hour Heart Rate at Day 1(Baseline, Day 1)
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14(Day 1, Day 14)
- Trough Forced Vital Capacity (FVC) at Day 1 and Day 14(Day 1 and Day 14)
- Change From Baseline in QTc (Fridericia's Formula) at Day 1(Baseline, Day 1)
- Change From Baseline in QTc (Fridericia's Formula) at Day 7(Baseline, Day 7)
- Change From Baseline in QTc (Fridericia's Formula) at Day 14(Baseline, Day 14)