Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
long-acting ß2-agonist, long-acting muscarinic antagonist, gas exchange, oxygen, small airways, lung capillary volume
Brief summary
The goal of this clinical trial was to compare the action of long-acting ß2-agonists (LABA-olodaterol) and muscarinic antagonists (LAMA-tiotropium) on tissue oxygenation in COPD considering their impact on proximal and peripheral ventilation and, eventually, on lung capillary volume. The hypothesis was that LABA would have a more peripheral effect than LAMA (due to the opposite gradient of their receptors) and better peripheral ventilation would result in a greater oxygenation. Before and after LABA (visit 1) and LAMA (visit 2) inhalation, COPD participants were asked to perform single-breath washout and forced oscillation tests, double diffusion technique and spirometry, while transcutaneous oxygenation was continuously recorded.
Detailed description
Slopes of He (SHe) and SF6 (SSF6) from single-breath washout test (SBWO) (assessing ventilation heterogeneities at the level of pre- and intra-acinar bronchioles, respectively) (quadruple model, LR6000 Logan-Sinclair, Rochester, UK), respiratory system resistance (R5, R5-R19) and reactance (X5, AX, Fres) from forced oscillation test (FOT) (Resmon Pro, ResTech, Italy), lung capillary volume (Vc) from double diffusion of NO and CO (DLNO/DLCO) (Hyp'Air compact, Medisoft, Dinant, Belgium), and FEV1 from spirometry (Zan®, Oberthulba, Germany) were evaluated before and after LABD administered via a spacer device: during the first visit, before, 30 minutes and 2 hours after inhalation of 4 puffs of 2,5 µg of olodaterol (LABA); during the second visit, before, 40 minutes and 2 hours after the administration of 4 puffs of 2,5 µg of tiotropium (LAMA). Transcutaneous oximetry (Perimed232©, Järfälla, Sweden) was monitored continuously during the 2 hours of each visit.
Interventions
Sponsors
Erasme University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
A prospective, clinical, uncontrolled, single-blind, cross-over trial that included 2 visits over 2-3 days. Assessments were performed before and after long-acting bronchodilation (LABD): during the first visit, before, 30 minutes and 2 hours after inhalation of olodaterol (LABA); during the second visit, before, 40 minutes and 2 hours after the administration of 4 puffs of 2,5 µg of tiotropium (LAMA).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD diagnosis according to international criteria
Exclusion criteria
* inability to perform the tests or to maintain the washout period * an exacerbation within the previous 6 weeks * a diagnosis of asthma or another chronic respiratory disease that could influence the results of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue oxygenation (TcO2) change from baseline | 120 minutes post-drug-administration | Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under reactance curve from 5 Hz (AX) change from baseline | 120 minutes post-drug administration | AX from forced oscillation test (FOT) evaluating the peripheral lung function |
| Reactance at 5 Hz (X5) change from baseline | 30 (LABA)/40 (LAMA) minutes post-drug administration | X5 from forced oscillation test (FOT) also evaluating the peripheral lung function |
| Resonant frequency (Fres) change from baseline | 120 minutes post-drug administration | Fres from forced oscillation test (FOT) also evaluating the peripheral lung function |
| Slope of Helium (SHe) change from baseline | 120 minutes post-drug administration | SHe from single-breath washout test (SBWO) assessing peripheral ventilation heterogeneities |
| Lung capillary volume (Vc) change from baseline | 120 minutes post-drug administration | Vc from single-breath double diffusion technique of nitric oxide (NO) and carbon monoxide (CO) (DLNO/DLCO) |
| Forced Expiratory Volume in 1 Second (FEV1) change from baseline | 120 minutes post-drug administration | FEV1 from spirometry |
| Peripheral resistance (R5-R19) change from baseline | 120 minutes post-drug administration | Peripheral resistance, assessed as frequency dependence of resistance (R5-R19) from forced oscillation test (FOT) also evaluating the peripheral lung function |
Countries
Belgium
Outcome results
None listed