A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 892
- 试验地点
- 1
- 主要终点
- Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
研究概览
简要总结
This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).
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
- •Participant in/completion of previous 24-week PINNACLE Phase III Trial.
- •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/forced vital capacity (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) New York Heart Association (NYHA) Class III/IV)
- •Clinically significant abnormal 12-lead electrocardiogram (ECG)
- •Abnormal liver function tests defined as alanine transaminase (ALT), aspartate transaminanse (AST), 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 (PT003)
干预措施: GFF MDI (PT 003) (Drug)
GP MDI (PT001)
干预措施: GP MDI (PT001) (Drug)
FF MDI (PT005)
干预措施: FF MDI (PT005) (Drug)
Open-label tiotropium bromide inhalation powder
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
干预措施: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®) (Drug)
结局指标
主要结局
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
时间窗: Baseline and Weeks 2 to 52
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
次要结局
- Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks(Baseline and Weeks 4 to 52)
- Change From Baseline in SGRQ Total Score(Baseline and Weeks 12 to 52)
- Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing(Baseline and Weeks 2 to 52)
- Change From Baseline in Average Daily Rescue Ventolin Use(Baseline through Week 52)