Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inhalation of bronchodilation therapy at FRC, Inhalation of bronchodilation therapy at RV.
- Who it may be relevant to
- Registry conditions: COPD, Lung Injury. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect on Bronchodilatation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD: the BREATH COPD Study
Overview
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.
Interventions
- Other 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 - Other 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
Primary outcome measures
- Efficacy of bronchodilation therapy inhaled at Functional Residual Capacity (FRC) on Forced Expiratory Volume in 1 second (FEV1) [Time frame: 1 year]
Secondary outcome measures (7)
- Effects on change in phase III slope of the closing volume curve [Time frame: 1 year]
- Effects on forced vital capacity (FVC) [Time frame: 1 year]
- Effects on vital capacity (VC) [Time frame: 1 year]
- Effects on residual volume (RV) [Time frame: 1 year]
- Effects on total lung capacity (TLC) [Time frame: 1 year]
- Effects on sensation of dyspnea as measured by modified Medical Research Council (mMRC) score [Time frame: 1 year]
- Effects on specific airway resistance (sRAW) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- age above 40 years old;
- history of smoking equal or above 10 PKYs;
- VEMS after bronchodilatation ≤ 70%,
- medical Necessity to perform a bronchodilatation test.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- L. Sacco Hospital — Milan
Identifiers
NCT: NCT05381415 · BREATHCOPD2022