NCT01854658已完成3 期
A Randomized, Double-Blind (Test Products and Placebo), 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
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
- 1,615
- 试验地点
- 2
- 主要终点
- Change From Baseline in Morning Pre-dose Trough FEV1
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI 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.
- •Subjects with FEV1/FVC ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.
- •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 NYHA Class III/IV)
- •Clinically significant abnormal 12-lead ECG
- •Abnormal liver function tests defined as AST, 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
FF MDI (PT005)
Experimental
FF MDI administered as two puffs BID
干预措施: FF MDI (PT005) (Drug)
GP MDI (PT001)
Experimental
GP MDI administered as two puffs BID
干预措施: GP MDI (PT001) (Drug)
GFF MDI (PT003)
Experimental
GFF MDI administered as two puffs BID
干预措施: GFF MDI (PT003) (Drug)
Placebo MDI
Placebo Comparator
Inhaled placebo administered as two puffs BID
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Morning Pre-dose Trough FEV1
时间窗: 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 HFA Use(24 weeks)
- St. George Respiratory Questionnaire (SGRQ) Score(24 weeks)
- Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks(Over 24 weeks)
- Peak FEV1(At week 24)
- Onset of Action as Assessed by FEV1(Day 1)
研究者
研究点 (2)
Loading locations...
相似试验
终止
3 期
GALLANT 2 Tesaglitazar vs. PlaceboType 2 DiabetesNCT00252772AstraZeneca80
终止
3 期
GALLANT 22 Tesaglitazar vs. PlaceboType 2 DiabetesNCT00252837AstraZeneca475
已完成
4 期
Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart FailureType 2 Diabetes MellitusHeart FailureNCT02917031AstraZeneca348
终止
3 期
GALLANT 7 Tesaglitazar Add-on to SulphonylureaType 2 DiabetesNCT00251940AstraZeneca555
终止
3 期
GALLANT 8 Tesaglitazar Add-on to MetforminType 2 DiabetesNCT00251953AstraZeneca555