NCT02196077已完成2 期
A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- FEV1 AUC0-12 on Day 29
研究概览
简要总结
This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
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
- •Informed Consent Form (ICF) prior to any study related procedures
- •COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- •Tobacco Use: Current or former smokers with a history of at least 10 pack years of cigarette smoking
- •Women of non-childbearing potential or medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
- •Severity of Disease: Subjects with an established clinical history of COPD and severity defined as: FEV1/forced vital capacity (FVC) ratio of <0.70; At Screening (Visit 1a/b), post bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III (Third National Health and Nutrition Examination Survey) reference equations; the measured FEV1 must also be ≥30% of predicted normal value; at Visit 2, the average of the 60 minutes and 30 minutes pre dose FEV1 assessments must be <80% predicted normal value calculated using NHANES III reference equations
- •Screening clinical laboratory tests must be acceptable to the Investigator
- •Screening ECG must be acceptable to the Investigator
- •Chest x ray or computerized tomography (CT) scan within 6 months prior to Visit 1a must be acceptable to the Investigator.
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
- •Pregnancy, nursing female subjects, or subjects trying to conceive, or not using medically acceptable form of contraception
- •Asthma: Subjects who have a primary diagnosis of asthma (Note: Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
- •Alpha 1 Antitrypsin Deficiency: Subjects who have alpha 1 antitrypsin deficiency as the cause of COPD -Active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea (ie., in the opinion of the Investigator severity of the disorder would impact the conduct of the study)-
- •Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- •Poorly Controlled COPD
- •History of ECG abnormalities
- •Cancer not in complete remission for at least 5 years
- •Clinically significant, symptomatic prostatic hypertrophy
- •Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
- •Clinically significant bladder neck obstruction or urinary retention
- •Inadequately treated glaucoma
- •History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
研究组 & 干预措施
BFF MDI 320/9.6 μg
Experimental
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
干预措施: BFF MDI 320/9.6 μg (Drug)
BFF MDI 160/9.6 μg
Experimental
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
干预措施: BFF MDI 160/9.6 μg (Drug)
BFF MDI 80/9.6 μg
Experimental
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
干预措施: BFF MDI 80/9.6 μg (Drug)
BD MDI 320 μg
Experimental
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
干预措施: BD MDI 320 μg (Drug)
FF MDI 9.6 μg
Experimental
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
干预措施: FF MDI 9.6 μg (Drug)
结局指标
主要结局
FEV1 AUC0-12 on Day 29
时间窗: Day 29
Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)
次要结局
- Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days(Over 28 days)
- Peak Change From Baseline in FEV1 (in Liters) Day 15(Day 15)
- Peak Change From Baseline in FEV1 (in Liters) Day 29(Day 29)
- Peak Change From Baseline in FEV1 on Day 1(Day 1)
- Forced Vital Capacity (FVC) AUC0-12 on Day 29(Day 29)
- Transition Dyspnea Index (TDI) Focal Score on Day 29(Day 29)
- Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment(Visit 12-13 (7 days))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPDChronic Obstructive Pulmonary Disease (COPD)NCT02109406Pearl Therapeutics, Inc.31
终止
3 期
Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPDCOPDNCT02685293Pearl Therapeutics, Inc.4
已完成
3 期
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPDChronic Obstructive Pulmonary Disease (COPD)NCT03836677AstraZeneca23
进行中（未招募）
不适用
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDModerate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 18.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 18.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855EUCTR2014-004712-10-GBPearl Therapeutics, Inc.1,614
进行中（未招募）
1 期
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDModerate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 19.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855EUCTR2014-004712-10-PLPearl Therapeutics, Inc.1,614