Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD

Официальное название

Effect on Bronchodilatation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD: the BREATH COPD Study

Обзор

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.

Вмешательства

• Другое Inhalation of bronchodilation therapy at FRC
  the patient will be asked to inhale the bronchodilator (salbutamol pMDI, 400 µg) with a spacer from FRC (functional residual capacity, in a random order, with the assistance of an operator. The spacer will be connected to a Fleish flowmeter placed in series with the pMDI device. The valve included in the spacer will guarantee that only the air inhaled by the patient will pass through the flowmeter, reducing the risk of contamination. In both cases a low inspiratory flux and a period of apnea af
• Другое Inhalation of bronchodilation therapy at RV
  the patient will be asked to inhale the bronchodilator (salbutamol pMDI, 400 µg) with a spacer from VR , with the assistance of an operator. The spacer will be connected to a Fleish flowmeter placed in series with the pMDI device. The valve included in the spacer will guarantee that only the air inhaled by the patient will pass through the flowmeter, reducing the risk of contamination. In both cases a low inspiratory flux and a period of apnea after inhalation of 10 seconds will be used. Before

Первичные конечные точки

• Efficacy of bronchodilation therapy inhaled at Functional Residual Capacity (FRC) on Forced Expiratory Volume in 1 second (FEV1) [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Effects on change in phase III slope of the closing volume curve [Срок оценки: 1 year]
• Effects on forced vital capacity (FVC) [Срок оценки: 1 year]
• Effects on vital capacity (VC) [Срок оценки: 1 year]
• Effects on residual volume (RV) [Срок оценки: 1 year]
• Effects on total lung capacity (TLC) [Срок оценки: 1 year]
• Effects on sensation of dyspnea as measured by modified Medical Research Council (mMRC) score [Срок оценки: 1 year]
• Effects on specific airway resistance (sRAW) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• age above 40 years old;
• history of smoking equal or above 10 PKYs;
• VEMS after bronchodilatation ≤ 70%,
• medical Necessity to perform a bronchodilatation test.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• L. Sacco Hospital — Milan

Идентификаторы

NCT: NCT05381415 · BREATHCOPD2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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