NCT01349803已完成2 期
A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Change From Baseline in 24-Hour Mean Heart Rate Post-dose
研究概览
简要总结
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •40 - 80 years of age
- •Clinical history of COPD with airflow limitation that is not fully reversible
- •Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- •Current/former smokers with at least a 10 pack-year history of cigarette smoking
- •A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
- •A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- •Able to change COPD treatment as required by protocol
- •Acceptable baseline (Visit 2) Holter monitor recording
排除标准
- •Women who are pregnant or lactating
- •Primary diagnosis of asthma
- •Alpha-1 antitrypsin deficiency as the cause of COPD
- •Active pulmonary diseases
- •Prior lung volume reduction surgery
- •Abnormal chest X-ray (or CT scan) not due to the presence of COPD
- •Hospitalized due to poorly controlled COPD within 3 months of Screening
- •Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- •Cancer that has not been in complete remission for at least 5 years
- •Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
- •Clinically significant abnormal findings during the baseline Holter recording
- •Patients with a pacemaker or ICD/CRT/CRT_D devices
- •Other inclusion/exclusion criteria as defined by the protocol
研究组 & 干预措施
PT003 MDI
Experimental
PT003 MDI
干预措施: PT003 MDI (Drug)
PT005 MDI
Experimental
PT005 MDI
干预措施: PT005 MDI (Drug)
PT001 MDI
Experimental
PT001 MDI
干预措施: PT001 MDI (Drug)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Active Comparator
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
干预措施: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (Drug)
结局指标
主要结局
Change From Baseline in 24-Hour Mean Heart Rate Post-dose
时间窗: 14 days
The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
次要结局
- Change From Baseline in Mean FEV1 Trough(Day 7 to Day 14)
- Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment(24 hours)
- Change From Baseline in Daytime Mean Heart Rate(Baseline, Day 1, and Day 14)
- Change From Baseline in Night Time Mean Heart Rate(Baseline, Day 1, and Day 14)
- Change From Baseline in 24-Hour Maximum Heart Rate(Baseline, Day 1, and Day 14)
- Change From Baseline in 24-Hour Minimum Heart Rate(Baseline, Day 1, and Day 14)
- Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring(Baseline, Day 1, and Day 14)
- Mean Change From Baseline in QTcF Interval(Baseline, Day 1, Day 7, and Day 14)
研究者
研究点 (1)
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