Pulmonary Gas Exchange Response to Indacaterol in Stable Symptomatic Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in PaO2 after indacaterol.
研究概览
简要总结
To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups.
Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.
详细描述
The investigators hypothesize that in stable chronic obstructive pulmonary disease (COPD) patients the interaction between intrapulmonary and extrapulmonary determinants contributing to gas exchange abnormalities after indacaterol will ultimately preserve arterial oxygenation (primary end-point outcome).
The study will include 20 outpatients with diagnosis of stable COPD in GOLD 2011 groups B and D (10 each), without frequent exacerbations (≥2 in the previous year). Patients with a COPD exacerbation within 3 months of study, use of long-term oxygen therapy and associated conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases) will be excluded.
Each patient will be studied on a single day. All subjects will remain on their regular treatment for the study. Subjects will be required to withhold SABAs for at least 12 h and LABAs and theophylline for at least 24 h before study. During measurements, patients will breath room air and will be seated in an armchair. Measurements will be performed before and 60 and 120 min after a single dose administration of indacaterol Breezhaler@ 300 mcg (1 inhalation).
After ensuring steady-state conditions, as assessed by stability (± 5%) of both ventilatory and hemodynamic variables, and by the close agreement (within ± 5%) between duplicate of mixed expired and arterial oxygen and carbon dioxide, a set of duplicate measurements for each variable will be obtained at each time point.
Blood samples will be collected through a catheter inserted under local anesthesia into the radial artery. Samples of blood (5 ml) will be removed for measurement of arterial O2 tension (PaO2), CO2 tension (PaCO2) and pH; alveolar-arterial PO2 difference (A-a)DO2, oxygen saturation (SaO2), and VO2, VCO2, Ve, respiratory rate (f), systemic arterial pressure (Psa), and heart rate (HR) will be measured or calculated, as previously described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Outpatients with COPD diagnosis according to GOLD 2011 criteria (VEF1/CVF less than 70%), groups B and D.
排除标准
- •Conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases).
- •Patients with frequent exacerbations (2 or more exacerbations in the past year).
- •History of acute COPD exacerbation in the previous 3 months.
研究组 & 干预措施
Indacaterol
Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
- Arterial blood gases
- Cardiac output
- Vital signs
- Exhaled breath
- Spirometry
干预措施: Arterial blood gases (Procedure)
Indacaterol
Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
- Arterial blood gases
- Cardiac output
- Vital signs
- Exhaled breath
- Spirometry
干预措施: Cardiac Output (Procedure)
Indacaterol
Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
- Arterial blood gases
- Cardiac output
- Vital signs
- Exhaled breath
- Spirometry
干预措施: Vital signs (Procedure)
Indacaterol
Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
- Arterial blood gases
- Cardiac output
- Vital signs
- Exhaled breath
- Spirometry
干预措施: Exhaled breath (Procedure)
Indacaterol
Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
- Arterial blood gases
- Cardiac output
- Vital signs
- Exhaled breath
- Spirometry
干预措施: Spirometry (Procedure)
Indacaterol
Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
- Arterial blood gases
- Cardiac output
- Vital signs
- Exhaled breath
- Spirometry
干预措施: Indacaterol (Drug)
结局指标
主要结局
Change in PaO2 after indacaterol.
时间窗: 60 and 120 minutes
次要结局
- Change in D(A-a)DO2 after indacaterol.(60 and 120 minutes)
- Change in PaCO2 after indacaterol.(60 and 120 minutes)
- Change in pH after indacaterol.(60 and 120 minutes)
- Change in cardiac output after indacaterol.(60 and 120 minutes)
研究者
Isabel Blanco
MD, PhD
Hospital Clinic of Barcelona