NCT00871182已完成1 期
A Randomized, Double-blind, Single Dose, Four-period, Six-treatment, Placebo-controlled, Balanced, Incomplete Block, Cross-over, Study of Four Doses of Inhaled PT001 in Patients With Mild to Moderate COPD, Compared to Open Label Tiotropium
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Peak improvement in forced expiratory volume in one second (FEV1)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •40 - 75 years of age
- •Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- •COPD diagnosis
- •Current/former smokers with at least a 10 pack-year history of cigarette smoking
- •Patients with established clinical history of COPD and severity defined as a post-ipratropium FEV1/FVC ratio of ≤0.70 and FEV1 ≥50 and ≤85% of predicted normal at Screening
- •Must demonstrate reversibility to ipratropium demonstrated by a >200 mL improvement over baseline and/or >12% and >150 mL improvement over baseline
- •Patients willing to stay at study site for at least 24 hours on each test day
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 24 weeks of Screening
- •Unable to perform acceptable spirometry
- •Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
- •Clinically significant medical conditions
- •Symptomatic prostatic hypertrophy or bladder neck obstruction
- •Known narrow-angle glaucoma
- •Lower respiratory tract infection requiring antibiotics in past 6 weeks
- •Clinically significant abnormal ECG
- •Clinically significant 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 anticholinergics
- •History of severe milk protein allergy
- •Known or suspected history of alcohol or drug abuse
- •Medically unable to withhold short acting bronchodilators for 6-hours
- •Use of the medications below in specified time interval prior to Screening: 3 months: depot corticosteroids, intra-articular corticosteroids; 6 weeks: oral corticosteroids, antibiotics administered for a COPD exacerbation; and 1 month: P-glycoprotein inhibitors, CYP450 3A4 inhibitors, ICS >1000 μg/day of fluticasone propionate or equivalent
- •The following COPD medications need to be stopped and switched to appropriate replacement therapies: tiotropium, oral beta2 agonists, LABAs, combination corticosteroid/LABAs, theophylline, leukotriene inhibitors,cromoglycate and nedocromil
- •Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates, hydantoins, and carbamazepine and phenothiazines
- •Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
- •Diagnosis of sleep apnea that is uncontrolled
- •Participation in acute phase of pulmonary rehabilitation in prior 4 weeks
- •Will enter acute phase of pulmonary rehabilitation program during study
- •Unable to comply with study procedures
- •Affiliated with Investigator site
- •Questionable validity of consent
- •Use of investigational study drug/participation in clinical study in the last 30 days or 5 half lives prior to Screening, whichever is longer
研究组 & 干预措施
PT001 18 mcg
Experimental
Inhaled PT001 18 mcg
干预措施: Inhaled PT001 (Drug)
PT001 36 mcg
Experimental
Inhaled PT001 36 mcg
干预措施: Inhaled PT001 (Drug)
PT001 72 mcg
Experimental
Inhaled PT001 72 mcg
干预措施: Inhaled PT001 (Drug)
PT001 144 mcg
Experimental
Inhaled PT001 144 mcg
干预措施: Inhaled PT001 (Drug)
Inhaled Placebo
Placebo Comparator
Inhaled Placebo
干预措施: Inhaled Placebo (Drug)
Tiotropium Handihaler
Active Comparator
Tiotropium 18 mcg administered via Handihaler
干预措施: Tiotropium Handihaler (Drug)
结局指标
主要结局
Peak improvement in forced expiratory volume in one second (FEV1)
时间窗: Day 1
Day 1 serial FEV1 measured over 24 hours
次要结局
- Peak Improvement in inspiratory capacity (IC)(Day 1)
- Time to onset of action (>10% improvement in FEV1 from baseline)(Day 1)
- Time to peak FEV1(Day 1)
- FEV1 area under the curve (AUC) from 0 to 24 hours(Day 1)
- FEV1 AUC from 0 to 12 hours(Day 1)
- Trough FEV1 at 12 and 24 hours(Day 1)
研究者
研究点 (6)
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