Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)
2017年2月7日 更新者：Pearl Therapeutics, Inc.
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
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).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
892
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Tauranga、新西兰
- Pearl Investigative Site
-
-
Aukland
-
Otahuhu、Aukland、新西兰
- Pearl Investigative Site
-
-
Dunedin
-
Caversham、Dunedin、新西兰
- Pearl Investigative Site
-
-
East Aukland
-
Greenlabe、East Aukland、新西兰
- Pearl Investigative Site
-
-
Waikato
-
Hamilton、Waikato、新西兰
- Pearl Investigative Site
-
-
Wellington
-
Newtown、Wellington、新西兰
- Pearl Investigative Site
-
-
-
-
New South Wales
-
New Lambton、New South Wales、澳大利亚
- Pearl Investigative Site
-
Westmead、New South Wales、澳大利亚
- Pearl Investigative Site
-
-
Queensland
-
Brisbane、Queensland、澳大利亚
- Pearl Investigative Site
-
Cairns、Queensland、澳大利亚
- Pearl Investigative Site
-
Wooloongabba、Queensland、澳大利亚
- Pearl Investigative Site
-
-
South Australia
-
Adelaide、South Australia、澳大利亚
- Pearl Investigative Site
-
-
Victoria
-
Heidelberg、Victoria、澳大利亚
- Pearl Investigative Site
-
-
Western Australia
-
Nederlands、Western Australia、澳大利亚
- Pearl Investigative Site
-
Perth、Western Australia、澳大利亚
- Pearl Investigative Site
-
-
-
-
Alabama
-
Andalusia、Alabama、美国
- Pearl Investigative Site
-
Anniston、Alabama、美国
- Pearl Investigative Site
-
Athens、Alabama、美国
- Pearl Investigative Site
-
Birmingham、Alabama、美国
- Pearl Investigative Site
-
Jasper、Alabama、美国
- Pearl Investigative Site
-
-
Arizona
-
Glendale、Arizona、美国
- Pearl Investigative Site
-
Mesa、Arizona、美国
- Pearl Investigative Site
-
Phoenix、Arizona、美国
- Pearl Investigative Site
-
Scottsdale、Arizona、美国
- Pearl Investigative Site
-
Tucson、Arizona、美国
- Pearl Investigative Site
-
-
California
-
Anaheim、California、美国
- Pearl Investigative Site
-
Carlsbad、California、美国
- Pearl Investigative Site
-
Lakewood、California、美国
- Pearl Investigative Site
-
Los Angeles、California、美国
- Pearl Investigative Site
-
Monterey Park、California、美国
- Pearl Investigative Site
-
Pasadena、California、美国
- Pearl Investigative Site
-
Poway、California、美国
- Pearl Investigative Site
-
Sacramento、California、美国
- Pearl Investigative Site
-
San Diego、California、美国
- Pearl Investigative Site
-
Tustin、California、美国
- Pearl Investigative Site
-
Vista、California、美国
- Pearl Investigative Site
-
-
Colorado
-
Colorado Springs、Colorado、美国
- Pearl Investigative Site
-
Denver、Colorado、美国
- Pearl Investigative Site
-
Fort Collins、Colorado、美国
- Pearl Investigative Site
-
Wheat Ridge、Colorado、美国
- Pearl Investigative Site
-
-
Connecticut
-
Danbury、Connecticut、美国
- Pearl Investigative Site
-
Waterbury、Connecticut、美国
- Pearl Investigative Site
-
-
Florida
-
Clearwater、Florida、美国
- Pearl Investigative Site
-
Miami、Florida、美国
- Pearl Investigative Site
-
Ormond Beach、Florida、美国
- Pearl Investigative Site
-
Panama City、Florida、美国
- Pearl Investigative Site
-
Pensacola、Florida、美国
- Pearl Investigative Site
-
St Petersburg、Florida、美国
- Pearl Investigative Site
-
Tampa、Florida、美国
- Pearl Investigative Site
-
Winter Park、Florida、美国
- Pearl Investigative Site
-
-
Georgia
-
Atlanta、Georgia、美国
- Pearl Investigative Site
-
Austell、Georgia、美国
- Pearl Investigative Site
-
Columbus、Georgia、美国
- Pearl Investigative Site
-
Duluth、Georgia、美国
- Pearl Investigative Site
-
Gainesville、Georgia、美国
- Pearl Investigative Site
-
-
Idaho
-
Couer d'aline、Idaho、美国
- Pearl Investigative Site
-
-
Illinois
-
Champaign、Illinois、美国
- Pearl Investigative Site
-
Evanston、Illinois、美国
- Pearl Investigative Site
-
Peoria、Illinois、美国
- Pearl Investigative Site
-
River Forest、Illinois、美国
- Pearl Investigative Site
-
-
Indiana
-
Avon、Indiana、美国
- Pearl Investigative Site
-
Evansville、Indiana、美国
- Pearl Investigative Site
-
South Bend、Indiana、美国
- Pearl Investigative Site
-
-
Iowa
-
Iowa City、Iowa、美国
- Pearl Investigative Site
-
-
Kansas
-
Olathe、Kansas、美国
- Pearl Investigative Site
-
Topeka、Kansas、美国
- Pearl Investigative Site
-
-
Kentucky
-
Louisville、Kentucky、美国
- Pearl Investigative Site
-
-
Louisiana
-
Lafayette、Louisiana、美国
- Pearl Investigative Site
-
Sunset、Louisiana、美国
- Pearl Investigative Site
-
-
Maryland
-
Hollywood、Maryland、美国
- Pearl Investigative Site
-
-
Michigan
-
Livonia、Michigan、美国
- Pearl Investigative Site
-
Southfield、Michigan、美国
- Pearl Investigative Site
-
-
Minnesota
-
Edina、Minnesota、美国
- Pearl Investigative Site
-
Fridley、Minnesota、美国
- Pearl Investigative Site
-
Minneapolis、Minnesota、美国
- Pearl Investigative Site
-
Woodbury、Minnesota、美国
- Pearl Investigative Site
-
-
Missouri
-
Chesterfield、Missouri、美国
- Pearl Investigative Site
-
Springfield、Missouri、美国
- Pearl Investigative Site
-
St Louis、Missouri、美国
- Pearl Investigative Site
-
-
Nebraska
-
Bellvue、Nebraska、美国
- Pearl Investigative Site
-
Omaha、Nebraska、美国
- Pearl Investigative Site
-
-
Nevada
-
Las Vegas、Nevada、美国
- Pearl Investigative Site
-
-
New Mexico
-
Albuquerque、New Mexico、美国
- Pearl Investigative Site
-
-
New York
-
Corning、New York、美国
- Pearl Investigative Site
-
-
North Carolina
-
Burlington、North Carolina、美国
- Pearl Investigative Site
-
Charlotte、North Carolina、美国
- Pearl Investigative Site
-
Greensboro、North Carolina、美国
- Pearl Investigative Site
-
Huntersville、North Carolina、美国
- Pearl Investigative Site
-
Mooresville、North Carolina、美国
- Pearl Investigative Site
-
Raleigh、North Carolina、美国
- Pearl Investigative Site
-
Wilmington、North Carolina、美国
- Pearl Investigative Site
-
Winston-Salem、North Carolina、美国
- Pearl Investigative Site
-
-
Ohio
-
Cincinnati、Ohio、美国
- Pearl Investigative Site
-
Dayton、Ohio、美国
- Pearl Investigative Site
-
-
Oregon
-
Bend、Oregon、美国
- Pearl Investigative Site
-
Brandon、Oregon、美国
- Pearl Investigative Site
-
Medford、Oregon、美国
- Pearl Investigative Site
-
Portland、Oregon、美国
- Pearl Investigative Site
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国
- Pearl Investigative Site
-
Pittsburgh、Pennsylvania、美国
- Pearl Investigative Site
-
-
South Carolina
-
Charleston、South Carolina、美国
- Pearl Investigative Site
-
Easley、South Carolina、美国
- Pearl Investigative Site
-
Gaffney、South Carolina、美国
- Pearl Investigative Site
-
Murrells Inlet、South Carolina、美国
- Pearl Investigative Site
-
Rock Hill、South Carolina、美国
- Pearl Investigative Site
-
Spartanburg、South Carolina、美国
- Pearl Investigative Site
-
-
South Dakota
-
Rapid City、South Dakota、美国
- Pearl Investigative Site
-
-
Tennessee
-
Bristol、Tennessee、美国
- Pearl Investigative Site
-
Johnson City、Tennessee、美国
- Pearl Investigative Site
-
Kingsport、Tennessee、美国
- Pearl Investigative Site
-
-
Texas
-
Austin、Texas、美国
- Pearl Investigative Site
-
Houston、Texas、美国
- Pearl Investigative Site
-
Huntsville、Texas、美国
- Pearl Investigative Site
-
Longview、Texas、美国
- Pearl Investigative Site
-
New Braunfels、Texas、美国
- Pearl Investigative Site
-
San Antonio、Texas、美国
- Pearl Investigative Site
-
-
Utah
-
Midvale、Utah、美国
- Pearl Investigative Site
-
Salt Lake City、Utah、美国
- Pearl Investigative Site
-
-
Vermont
-
South Burlington、Vermont、美国
- Pearl Investigative Site
-
-
Virginia
-
Abingdon、Virginia、美国
- Pearl Investigative Site
-
Richmond、Virginia、美国
- Pearl Investigative Site
-
-
Washington
-
Spokane、Washington、美国
- Pearl Investigative Site
-
Tacoma、Washington、美国
- Pearl Investigative Site
-
-
West Virginia
-
Morgantown、West Virginia、美国
- Pearl Investigative Site
-
-
Wisconsin
-
West Allis、Wisconsin、美国
- Pearl Investigative Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- 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 1.
- 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
Key Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：开放标签噻托溴铵吸入粉
开放标签噻托溴铵吸入粉 (Spiriva® Handihaler®)
|
Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
|
|
实验性的：GFF MDI (PT003)
|
GFF MDI administered as two puffs BID
|
|
实验性的：GP MDI (PT001)
|
GP MDI 作为两次喷出 BID
|
|
实验性的：FF MDI (PT005)
|
FF MDI 两次喷出 BID
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
大体时间：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.
|
Baseline and Weeks 2 to 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
大体时间：Baseline and Weeks 4 to 52
|
SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline.
The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort).
TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.
|
Baseline and Weeks 4 to 52
|
|
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
大体时间：Baseline and Weeks 2 to 52
|
Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population).
Peak FEV1 was assessed at multiple visits 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 Peak FEV1 post-baseline.
|
Baseline and Weeks 2 to 52
|
|
Change From Baseline in SGRQ Total Score
大体时间：Baseline and Weeks 12 to 52
|
The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD.
The scores range from 0 (best possible health status) to 100 (worst possible health status).
The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts).
Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated.
The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
|
Baseline and Weeks 12 to 52
|
|
Change From Baseline in Average Daily Rescue Ventolin Use
大体时间：Baseline through Week 52
|
Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day.
The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period.
Missing values were ignored in both the numerator and denominator.
Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average.
Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.
|
Baseline through Week 52
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2013年10月18日
首先提交符合 QC 标准的
2013年10月22日
首次发布 (估计)
2013年10月28日
研究记录更新
最后更新发布 (实际的)
2017年3月17日
上次提交的符合 QC 标准的更新
2017年2月7日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.