Effects of Acute Long-acting Bronchodilation on Oxygenation and Peripheral Ventilation in COPD

Free University of Brussels (ULB)

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: LABA; Drug: LAMA

Study type: Interventional

Funder types: Other

Identifiers

NCT05927155

SRB-201903-052

P2019/239 CCB: B406201939717 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

LABA (olodaterol)

Experimental group

Description:

After 4-5 days washout period, during the first visit, participants received a long-acting beta2-agonist (LABA)

Treatment:

Drug: LABA

LAMA (tiotropium)

Experimental group

Description:

Two days after the first visit, during the second visit , participants received a long-acting muscarinic antagonist (LAMA)

Treatment:

Drug: LAMA