NCT01566773已完成2 期
A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
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
- 140
- 试验地点
- 1
- 主要终点
- FEV1 AUC0-12
研究概览
简要总结
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
详细描述
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
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
PT001 Placebo MDI
Placebo Comparator
干预措施: PT001 Placebo MDI (Drug)
PT001 MDI (Dose 1)
Experimental
干预措施: PT001 MDI (Drug)
PT001 MDI (Dose 2)
Experimental
干预措施: PT001 MDI (Drug)
PT001 MDI (Dose 3)
Experimental
干预措施: PT001 MDI (Drug)
PT001 MDI (Dose 4)
Experimental
干预措施: PT001 MDI (Drug)
PT001 MDI (Dose 5)
Experimental
干预措施: PT001 MDI (Drug)
PT001 MDI (Dose 6)
Experimental
干预措施: PT001 MDI (Drug)
Spiriva® Handihaler® (Tiotropium Bromide)
Active Comparator
干预措施: Tiotropium Bromide (Drug)
结局指标
主要结局
FEV1 AUC0-12
时间窗: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
次要结局
- Peak Change From Baseline in FEV1(Day 14)
- Time to Onset of Action (>10% Improvement in FEV1) on Day 1(Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs))
- Percentage of Subjects Achieving at Least 12% Improvement in FEV1(Day 1)
- Peak Change From Baseline in Inspiratory Capacity (IC)(Day 1 (1 hr and 2 hr post-dose ))
- Change From Baseline in Morning Pre-dose Trough FEV1(Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline))
- Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)(Day 7)
- Peak Change From Baseline in IC(Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline))
- Change From Baseline in Mean Morning Pre-dose Daily PEFR(Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7))
- Change From Baseline in Morning Post-dose Daily PEFR(Day 7 (30 minutes post-dose))
- Change From Baseline in Mean Evening Pre-dose PEFR(Day 7)
- Change From Baseline in Mean Evening Post-dose PEFR(Day 7)
- Mean Number of Puffs of Rescue Medication(Day 7)
- Change From Baseline for Mean Morning Pre-dose Trough IC(Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline))
- Change From Baseline in 12-hour Post-dose Trough FEV1(Day 14 (Baseline, 11.5 and 12 hours post dose))
- Change From Baseline in Mean Morning Post-dose Daily PEFR(Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7))
- Change From Baseline in Mean Evening Pre-dose Daily PEFR(Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7))
- Change From Baseline in Mean Evening Post-dose Daily PEFR(Through the end of the 14-Day Treatment)
- Mean Number of Puffs of Rescue Medication (End of Treatment)(Day 14 (End of treatment))
- Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14(Day 1 through Day 14)
研究者
研究点 (1)
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