NCT02347072已完成3 期
A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24
研究概览
简要总结
Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.
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 Screening
- •Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.
- •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 of <0.70
- •Post-bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 <30% of predicted normal value.
排除标准
- •Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- •Women who are pregnant or lactating.
- •Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- •Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period.
- •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 who have cancer that has not been in complete remission for at least five years.
- •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.
- •Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
- •Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.
- •Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
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)
Spiriva® Respimat® (Tiotropium Bromide)
Active Comparator
Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)
干预措施: Spiriva® Respimat® (Tiotropium Bromide) (Drug)
结局指标
主要结局
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24
时间窗: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29
Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24
次要结局
- Peak Change From Baseline in FEV1 Morning(Baseline and Day 29)
- Morning Pre-Dose Trough FEV1 on Day 30(Day 30)
- Peak Change From Baseline in IC Morning(Baseline and Day 29)
- FEV1 AUC12-24(Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29)
- Morning Pre-Dose Trough FEV1 on Day 29(Day 29)
- Peak Change From Baseline in IC (Inspiratory Capacity) Evening(Baseline and Day 29)
- FEV1 AUC0-12(Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29)
- Peak Change From Baseline in FEV1 Evening(Baseline and Day 29)
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