Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of Milan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age above 40 years old;
history of smoking equal or above 10 PKYs;
VEMS after bronchodilatation ≤ 70%,
medical Necessity to perform a bronchodilatation test.
Disqualifiers
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;
Trial population
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 \[GOLD\].
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Inhalation of bronchodilation therapy at FRC
Other interventionthe 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 after inhalation of 10 seconds will be used. 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. These will allow the characterization of the bronchodilator effect in terms of static and dynamic volumes, heterogeneity of ventilation distribution and volume of closure, expiration flux-limitation.
Inhalation of bronchodilation therapy at RV
Other interventionthe 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 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. These will allow the characterization of the bronchodilator effect in terms of static and dynamic volumes, heterogeneity of ventilation distribution and volume of closure, expiration flux-limitation.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with COPD2 interventions
Trial outcomes
Primary outcomes
1
Efficacy of bronchodilation therapy inhaled at Functional Residual Capacity (FRC) on Forced Expiratory Volume in 1 second (FEV1)
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.
Time frame
1 yearSecondary outcomes
1
Effects on change in phase III slope of the closing volume curve
Efficacy of bronchodilation therapy inhaled at FRC on reducing phase III slope of the closing volume, as compared to bronchodilation therapy inhaled at RV
Time frame
1 year2
Effects on forced vital capacity (FVC)
Efficacy of bronchodilation therapy inhaled at FRC on static and dynamic lung volumes as compared to bronchodilation therapy inhaled at RV
Time frame
1 year3
Effects on vital capacity (VC)
Efficacy of bronchodilation therapy inhaled at FRC on static and dynamic lung volumes as compared to bronchodilation therapy inhaled at RV
Time frame
1 year4
Effects on residual volume (RV)
Efficacy of bronchodilation therapy inhaled at FRC on static and dynamic lung volumes as compared to bronchodilation therapy inhaled at RV
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Milan
Lead sponsor
Department of Clinical and Surgical Pathophysiology and Transplantation, University of Milan
Collaborator
Source ClinicalTrials.gov
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