Clinical trial NCT05381415: Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD
Official title: Effect on Bronchodilatation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD: the BREATH COPD Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Lung Injury
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Department of Clinical and Surgical Pathophysiology and Transplantation, University of Milan
First posted: 2022-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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 \[GOLD\].

Brief summary: 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: 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.

Primary outcomes:
measure: Efficacy of bronchodilation therapy inhaled at Functional Residual Capacity (FRC) on Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 1 year
Secondary outcomes:
measure: Effects on change in phase III slope of the closing volume curve
timeFrame: 1 year
measure: Effects on forced vital capacity (FVC)
timeFrame: 1 year
measure: Effects on vital capacity (VC)
timeFrame: 1 year
measure: Effects on residual volume (RV)
timeFrame: 1 year
measure: Effects on total lung capacity (TLC)
timeFrame: 1 year
measure: Effects on sensation of dyspnea as measured by modified Medical Research Council (mMRC) score
timeFrame: 1 year
measure: Effects on specific airway resistance (sRAW)
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: L. Sacco Hospital
Study officials:
References: