NCT01349816已完成2 期
A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- FEV1 AUC0-12
研究概览
简要总结
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (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
- 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
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
- •Other inclusion/exclusion criteria as defined in the protocol
研究组 & 干预措施
PT003 (Dose 2)
Experimental
PT003 MDI Dose 2
干预措施: PT003 (Drug)
PT003 (Dose 3)
Experimental
PT003 MDI Dose 3
干预措施: PT003 (Drug)
PT003 (Dose 4)
Experimental
PT003 MDI Dose 4
干预措施: PT003 (Drug)
PT003 (Dose 1)
Experimental
PT003 MDI Dose 1
干预措施: PT003 (Drug)
PT001
Experimental
PT001 MDI
干预措施: PT001 (Drug)
PT005
Experimental
PT005 MDI
干预措施: PT005 (Drug)
结局指标
主要结局
FEV1 AUC0-12
时间窗: Day 7
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
次要结局
- Peak Change From Baseline in IC(Day 7)
- Time to Onset of Action(Day 1)
- At Least 12% Improvement in FEV1(Day 1)
- Morning Pre-dose FEV1(Day 7)
- Peak Change From Baseline in FEV1(Day 1)
- Peak Change in IC(Day 1)
- FEV1 Through 6 Hours(Day 7)
- Mean Evening Trough FEV1(Day 7)
研究者
研究点 (1)
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