Effect on Bronchodilatation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD: the BREATH COPD Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy of bronchodilation therapy inhaled at Functional Residual Capacity (FRC) on Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
During bronchodilator tests, it's common to ask patients with asthma or chronic obstructive pulmonary disease (COPD) to take bronchodilator therapy by inhaling after a maximal exhalation, when the respiratory system volume equals the residual volume. The same maneuver is required for the chronic therapy.
Nevertheless, in patients with COPD the distribution of ventilation is more heterogeneous, especially when lung volumes are closer to residual volume . It is therefore predictable that the distribution of air volume containing bronchodilator that has been inhaled at residual volume is more heterogeneous than at higher volumes, such as at functional residual capacity. Accordingly, the bronchodilator can be preferentially distributed in more open airways than in less patent ones, with a heterogeneous distribution of the medication. Therefore, the overall bronchodilation should be greater when the drug inhalation is performed at functional residual capacity than at residual volume.
It is common knowledge that the effectiveness of bronchodilator therapy with pMDI in subjects with COPD is greatly affected by the inhalation technique, which can be difficult to perform for many patients. Therefore, in addition to the possibility that inhalation of bronchilation therapy at residual volume could lower the drug effectiveness, this maneuver complicates the sequence of actions required to the patient, enhancing the risk of errors and decreasing the aderence to treatment.
The aim of this study is to investigate whether the inhalation of a bronchodilator at different lung volumes can affect its effectiveness in terms of respiratory function, in patients with COPD.
Assuming that the bronchodilator effectiveness is equal or greater when inhaled at functional residual capacity rather than at residual volume, the inhalation maneuver can be simplified for patients with COPD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 40 years old;
- •history of smoking equal or above 10 PKYs;
- •VEMS after bronchodilatation ≤ 70%,
- •medical Necessity to perform a bronchodilatation test.
排除标准
- •history of bronchial asthma or other chronic respiratory diseases such as pulmonary fibrosis;
- •uncontrolled cardiovascular diseases at the time of the visit;
- •current pregnancy;
- •incapacity to execute lung function tests for cognitive impairment, substance abuse or claustrophobia;
- •known hypersensitivity or intolerance to salbutamol.
研究组 & 干预措施
Patients with COPD
Patients with COPD diagnosis (VEMS/FVC after bronchodilatation <0.7) will be enrolled in a stable state of disease, diagnosed from at least 12 months [GOLD].
Each patient will be studied during three visits. In the first visit it will be established the patient eligibility. Furthermore, the patient will be able to familiarize with the experimental procedure. Chronic inhalation therapy will be suspended 24 (long action) and 8 (short action) hours before the second and third visit. If a patient is on tiotropium bromide, it will be required to be suspended 7 days before the visit.
During the second and third visit, which will be scheduled 30 days one from another, the patient will be asked to inhale the bronchodilator (salbutamol pMDI, 400 µg) with a spacer from VR or FRC, in a random order. Before and after the administration it will be asked to the patient to execute a spirometry, a plethysmography, a lung diffusion test, and the NEP technique.
干预措施: Inhalation of bronchodilation therapy at FRC (Other)
Patients with COPD
Patients with COPD diagnosis (VEMS/FVC after bronchodilatation <0.7) will be enrolled in a stable state of disease, diagnosed from at least 12 months [GOLD].
Each patient will be studied during three visits. In the first visit it will be established the patient eligibility. Furthermore, the patient will be able to familiarize with the experimental procedure. Chronic inhalation therapy will be suspended 24 (long action) and 8 (short action) hours before the second and third visit. If a patient is on tiotropium bromide, it will be required to be suspended 7 days before the visit.
During the second and third visit, which will be scheduled 30 days one from another, the patient will be asked to inhale the bronchodilator (salbutamol pMDI, 400 µg) with a spacer from VR or FRC, in a random order. Before and after the administration it will be asked to the patient to execute a spirometry, a plethysmography, a lung diffusion test, and the NEP technique.
干预措施: Inhalation of bronchodilation therapy at RV (Other)
结局指标
主要结局
Efficacy of bronchodilation therapy inhaled at Functional Residual Capacity (FRC) on Forced Expiratory Volume in 1 second (FEV1)
时间窗: 1 year
Assuming that the bronchodilator effectiveness is equal or greater when inhaled at functional residual capacity rather than at residual volume, the inhalation maneuver can be simplified for patients with COPD.
次要结局
- Effects on total lung capacity (TLC)(1 year)
- Effects on forced vital capacity (FVC)(1 year)
- Effects on sensation of dyspnea as measured by modified Medical Research Council (mMRC) score(1 year)
- Effects on specific airway resistance (sRAW)(1 year)
- Effects on change in phase III slope of the closing volume curve(1 year)
- Effects on vital capacity (VC)(1 year)
- Effects on residual volume (RV)(1 year)
研究者
Pierachille Santus, MD, PhD
Professor of Pulmonary Medicine
University of Milan