A Double-Blind, Crossover Study to Assess the Effects of Nebulized Brovana Added to Tiotropium on FEV1, Hyperinflation, and Exercise Endurance Capacity in COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week
研究概览
简要总结
This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.
详细描述
Hypotheses to be tested:
Brovana nebulized twice daily added to maintenance inhaled tiotropium therapy in stable COPD patients increases:
- Forced expiratory volume in 1 second (FEV1) at peak dose effect (approximately 2 hours after AM dosing in the laboratory)
- Resting and exercise hyperinflation at peak dose effect (inspiratory capacity (IC) at baseline and at iso-time during exercise testing; these measurements will be approximately 2 ¼ hours after AM dosing of tiotropium plus test drug.
- Exercise treadmill endurance time at peak dose effect (approximately 2 ¼ hours after AM dosing in the laboratory)
Patients: Twenty patients will be studied
Location: Section of Pulmonary and Critical Care, St. Francis Hospital & Medical Center, Hartford, CT
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
- •Adults, age > 40 years
- •A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( < 0.70
- •Moderate, severe and very severe airflow limitation by GOLD criteria.
- •Clinically stable respiratory disease
- •The perceived ability to participate in pulmonary testing and exercise testing
- •COPD, stable state
- •Exclusion criteria:
- •Women of childbearing potential
- •Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
- •Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
- •An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
- •A history of a prolonged QT interval
- •Recent exacerbation of COPD
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo twice daily for 1 week
干预措施: Placebo (Drug)
Arformoterol
Arformoterol twice daily for 1 week via nebulizer
干预措施: Arformoterol (Brovana) (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week
时间窗: baseline and 1 week
Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)
次要结局
- Change From Baseline in Forced Vital Capacity (FVC) at 1 Week(baseline and 1 week)
- Change From Baseline in Inspiratory Capacity at 1 Week(baseline and 2 hours after dosing)