Effects of Acute Long-acting Bronchodilation on Oxygenation and Peripheral Ventilation in COPD
- Registration Number
- NCT05927155
- Lead Sponsor
- Erasme University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- COPD diagnosis according to international 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LABA (olodaterol) LABA After 4-5 days washout period, during the first visit, participants received a long-acting beta2-agonist (LABA) LAMA (tiotropium) LAMA Two days after the first visit, during the second visit , participants received a long-acting muscarinic antagonist (LAMA)
- Primary Outcome Measures
Name Time Method Tissue oxygenation (TcO2) change from baseline 30 (LABA)/40 (LAMA) minutes post-drug administration Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter
- Secondary Outcome Measures
Name Time Method Resonant frequency (Fres) change from baseline 30 (LABA)/40 (LAMA) minutes post-drug administration Fres from forced oscillation test (FOT) also evaluating the peripheral lung function
Peripheral resistance (R5-R19) change from baseline 30 (LABA)/40 (LAMA) 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
Lung capillary volume (Vc) change from baseline 30 (LABA)/40 (LAMA) minutes post-drug administration Vc from single-breath double diffusion technique of nitric oxide (NO) and carbon monoxide (CO) (DLNO/DLCO)
Slope of Helium (SHe) change from baseline 30 (LABA)/40 (LAMA) minutes post-drug administration SHe from single-breath washout test (SBWO) assessing peripheral ventilation heterogeneities
Area under reactance curve from 5 Hz (AX) change from baseline 30 (LABA)/40 (LAMA) 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
Forced Expiratory Volume in 1 Second (FEV1) change from baseline 30 (LABA)/40 (LAMA) minutes post-drug administration FEV1 from spirometry
Trial Locations
- Locations (1)
Erasme University Hospital
🇧🇪Brussels, Belgium