Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intra Thoracic Gas Volume (ITGV)
研究概览
简要总结
The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.
详细描述
Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.
Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.
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)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of consensus
- •COPD diagnosis
- •Age from 50 to 85 years old
- •history of COPD at least of one year
- •respiratory stable conditions at least of one month
- •Any basal FEV1 expressed in % of predicted value
- •FEV1/ Forced Vital Capacity (FVC) less than 70%
- •Former or active smokers with at least a smoking history of 20 pack year
排除标准
- •Pregnancy
- •FEV1/FVC more than 70%
- •Known deficit of alpha 1 antitrypsin
- •Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
- •Subjects with known positivity to Human Immunodeficiency Virus (HIV)
- •Misuse of alcool or drugs
- •Absence of compliance in performing respiratory tests
研究组 & 干预措施
Bronchodilator
Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.
干预措施: Indacaterol maleate (Drug)
Placebo
Will be administered with the same device by a third independent investigator
干预措施: Placebo (Drug)
结局指标
主要结局
Intra Thoracic Gas Volume (ITGV)
时间窗: 60 minutes after drug inhalation
A complete body plethysmografic test will be performed after indacaterol inhalation
次要结局
- Forced Expired Volume in the first second (FEV1)(60 minutes after drug inhalation)
- Partial pressure of arterial oxygen (PaO2)(60 minutes after drug inhalation)
研究者
Pierachille Santus
MD, PhD
University of Milan