A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,756
- 试验地点
- 1
- 主要终点
- Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
研究概览
简要总结
A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
详细描述
A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- •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.
- •Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.
- •FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).
排除标准
- •Significant diseases other than COPD, ie, 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 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 Screening Period (Visit 1 to Visit 4).
- •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 Screening Period (Visit 1 to Visit 4).
- •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 who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
研究组 & 干预措施
GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
干预措施: GFF MDI (PT003) (Drug)
FF MDI (PT005)
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
干预措施: FF MDI (PT005) (Drug)
GP MDI (PT001)
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
干预措施: GP MDI (PT001) (Drug)
Placebo MDI
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
干预措施: Placebo MDI (Drug)
结局指标
主要结局
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
时间窗: at week 24
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach
时间窗: over weeks 12-24
Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.
时间窗: over 24 weeks
Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.
次要结局
- TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population(over 24 Weeks)
- Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach(at week 24)
- Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach(over weeks 12-24)
- Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach(over 24 weeks)
- Change From Baseline in SGRQ Total Score at Week 24, US/China Approach(at week 24)
- TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach(over 24 Weeks)
- TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population(over weeks 12-24)
- TDI Focal Score Over Weeks 12-24 Japan Approach(over Weeks 12-24)
- Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach(over weeks 12-24)
- Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach(at week 24)
- Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach(over weeks 12-24)
- Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches(over 24 weeks)
- FEV1 Measured at 5 Minutes Post-dose on Day 1(Assessed at 5-minutes post dose on Day 1)
- FEV1 Measured at 15 Minutes Post-dose on Day 1(Assessed at 15-minute post dose on Day 1)