NCT01043601撤回2 期
A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled, Multi-dose, Four-period, Cross-over Study of Two Doses of Formoterol Fumarate MDI (PT005; 7.2 and 9.6 µg Ex-actuator), Administered Twice Daily for 1 Week in Patients With Moderate to Very Severe COPD, Compared to Open Label Marketed Formoterol Fumarate Inhalation Powder (Foradil® Aerolizer®, 12 µg) as an Active Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (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
- 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
- •Signed written informed consent
- •40 - 80 years of age
- •Fluency in written and spoken English
- •Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- •Current/former smokers with at least a 10 pack-year history of cigarette smoking
- •A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
- •A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- •Competent at using the inhalation device
排除标准
- •Women who are pregnant or lactating
- •Primary diagnosis of asthma
- •Alpha-1 antitrypsin deficiency as the cause of COPD
- •Active pulmonary diseases
- •Prior lung volume reduction surgery
- •Abnormal chest X-ray (or CT scan) not due to the presence of COPD
- •Hospitalized due to poorly controlled COPD within 12 weeks of Screening
- •Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2
- •Lower respiratory tract infection requiring antibiotics within 6 weeks of screening
- •Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or uncontrolled hypertension)
- •Positive Hepatitis B surface antigen or Hepatitis C antibody
- •Cancer that has not been in complete remission for at least 5 years
- •History of hypersensitivity to any beta2-agonists or any study drug component
- •History of severe milk protein allergy
- •Known or suspected history of alcohol or drug abuse
- •Medically unable to withhold short acting bronchodilators for 8-hours
- •Use of prohibited medications prior to screening and during the study as specified in the protocol
- •Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
- •Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study
- •Unable to comply with study procedures
- •Prior participation in a Pearl PT005 study
- •Requires use of a spacer due to poor hand-to-breath coordination
研究组 & 干预措施
Inhaled PT005 7.2 µg
Experimental
干预措施: Inhaled PT005 (Drug)
Inhaled PT005 9.6 µg
Experimental
干预措施: Inhaled PT005 (Drug)
Inhaled Placebo
Placebo Comparator
干预措施: Inhaled Placebo (Drug)
Formoterol Fumarate 12 µg (Foradil Aerolizer)
Active Comparator
干预措施: Formoterol Fumarate 12 µg (Foradil Aerolizer) (Drug)
结局指标
主要结局
Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo.
时间窗: Day 7
次要结局
- Lung Function Measures on Day 7 as measured by spirometry.(Day 7)
- Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest(Day 7)
研究者
研究点 (1)
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