NCT01854645已完成3 期
A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
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
- 2,103
- 试验地点
- 1
- 主要终点
- Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
研究概览
简要总结
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
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
- 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
- •Male or female subjects at least 40 years of age and no older than 80 at 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.
- •Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
- •Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol
排除标准
- •Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
- •Current diagnosis of asthma or alpha-1 antitrypsin deficiency
- •Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
- •Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
- •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
- •Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
- •Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
- •Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
- •Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
- •Clinically significant abnormal 12-lead ECG
- •Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
- •Cancer not in complete remission for at least five years
- •History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
GFF MDI
Experimental
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)
干预措施: GFF MDI (Drug)
GP MDI
Experimental
Glycopyrronium (GP) MDI (PT001)
干预措施: GP MDI (Drug)
FF MDI
Experimental
Formoterol Fumarate (FF) MDI (PT005)
干预措施: FF MDI (Drug)
Open-label tiotropium bromide inhalation powder
Active Comparator
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
干预措施: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) (Drug)
Placebo
Placebo Comparator
Placebo MDI
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
时间窗: Baseline and at Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
次要结局
- Rescue Ventolin Hydrofluoroalkane (HFA) Use(Baseline and at Week 24)
- Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks(Baseline and Weeks 2 to 24)
- St. George's Respiratory Questionnaire (SGRQ) Score(Baseline and at Week 24)
- Onset of Action as Assessed by FEV1(Assessed for 5- and 15-minute post dose on Day 1)
- Peak Change From Baseline in FEV1 Within 2 Hours Post-dose(Baseline and at Week 24)
研究者
研究点 (1)
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