NCT02937584已完成3 期
A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.
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
- 23
- 试验地点
- 1
- 主要终点
- Specific Image-Based Airway Volume (siVaw)
研究概览
简要总结
To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
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
- •Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
- •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.
- •At Visit 1, FEV1/FVC ratio must be <0.70
- •At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.
- •Exclusion criteria:
- •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, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- •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 Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
- •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 Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
- •Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
- •Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
排除标准
- 未提供
研究组 & 干预措施
GP MDI (PT001) 14.4 μg
Experimental
Glycopyrronium
干预措施: GP MDI (PT001) 14.4 μg (Drug)
FF MDI (PT005) 9.6 μg
Experimental
Formoterol Fumarate
干预措施: FF MDI (PT005) 9.6 μg (Drug)
结局指标
主要结局
Specific Image-Based Airway Volume (siVaw)
时间窗: Baseline, Day 15
Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline
Specific Image-based Airway Resistance (siRaw)
时间窗: Baseline, Day 15
Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.
次要结局
- FEV1(Baseline, Day 15)
- Image-based Airway Resistance (iRaw)(Baseline, Day 15)
- Image-based Airway Volume (iVaw)(Baseline, Day 15)
- Functional Residual Capacity (FRC)(Baseline, Day 15)
研究者
研究点 (1)
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