NCT02685293终止3 期
A Randomized, Phase IIIb, Two-period , Double-blind, Two-treatment, Chronic-dosing (7 Days), Single-center Crossover Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease, Compared With Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVi) at 2-3 Hours Post-dose on Day 8
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects 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, Care Provider, Investigator)
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
- •At least 40 years of age and no older than 80 at Visit
- •Women of non-child bearing potential,or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly from Screening until 14 days after final visit
- •Evidence of lung hyperinflation
- •Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- •Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- •Pre- and Post-bronchodilator FEV1/FVC ratio must be <0.70
- •Post-bronchodilator FEV1 must be ≥30% to <65% predicted normal value, calculated using NHANES III reference equations.
排除标准
- •Significant diseases or conditions other than COPD which, in the opinion of the Investigator, may put the patient at risk
- •Women who are pregnant or lactating or are planning to become pregnant during the course of the study
- •Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma or other active pulmonary disease
- •Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening
- •Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period
- •Subjects who have clinically significant uncontrolled hypertension.
- •Subjects with symptomatic prostatic hypertrophy that is clinically significant and not adequately controlled with appropriate therapy, in the opinion of the Investigator.
- •Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
- •Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat testing prior to Visit
- •Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2
- •Subjects who have cancer that has not been in complete remission for at least five years.
- •Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have not been adequately treated.
- •Subjects with a clinically significant ECG
- •Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study conducted or sponsored by Pearl.
研究组 & 干预措施
GFF MDI (PT003)
Experimental
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
干预措施: GFF MDI (PT003) (Drug)
Placebo MDI
Placebo Comparator
Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
干预措施: Placebo MDI (Drug)
结局指标
主要结局
Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVi) at 2-3 Hours Post-dose on Day 8
时间窗: Baseline and Day 8 of either treatment period 1 or 2, as applicable.
Assessment of right ventricular (RV) volume was performed using magnetic resonance imaging (MRI) using RV end diastolic volume (RVEDV), 2-3 hours after dosing on Day 8 of each treatment period. RVEDV was normalized to body surface area (BSA) to provide the indexed counterpart (RVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.
次要结局
- Change From Baseline in Right Ventricular Stroke Volume (RVSV) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Left Atrial End Diastolic Volume (LAEDV) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Pulmonary Artery Velocity at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Cardiac Output at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Pulmonary Artery/Aortic Diameter Ratio (PA:A) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Left Atrial End Systolic Volume (LAESV) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Left Atrial Ejection Fraction (LAEF) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVi) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Pulsatility Index Aorta (PIAo) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Aortic Left Ventricular Stroke Volume (LVSV) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Pulmonary Vascular Resistance (PVR) at 30 and 60 Minutes Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Right Ventricular End Systolic Volume Index (RVESVi) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
- Change From Baseline in Pulmonary Artery Pulsatility Index (PAPi) at 2-3 Hours Post-dose on Day 8(Baseline and Day 8 of either treatment period 1 or 2, as applicable.)
研究者
研究点 (1)
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