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NCT05381415Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
4 May 2022
Start date
1 Dec 2026
Primary completion date
1 Dec 2027
Lead sponsor
University of Milan
Diseases
COPD
NCT number
NCT05381415

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 1 Dec 2026 to the primary completion date, 1 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • history of bronchial asthma or other chronic respiratory diseases such as pulmonary fibrosis;
  • uncontrolled cardiovascular diseases at the time of the visit;
  • incapacity to execute lung function tests for cognitive impairment, substance abuse or claustrophobia;
  • known hypersensitivity or intolerance to salbutamol.

Other

  • current pregnancy;

Who the study is looking for

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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
L. Sacco Hospital
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.