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Completed

NCT Number: NCT05927155

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LABA

Drug

Inhalation of 4 puffs of 2,5 µg of a long-acting beta2-agonist (LABA-olodaterol) administered via a spacer device

Other names: Olodaterol, Striverdi Respimat

LAMA

Drug

Inhalation of 4 puffs of 2,5 µg of a long-acting muscarinic antagonist (LAMA-tiotropium) administered via a spacer device

Other names: Tiotropium, Spiriva Respimat

Primary outcomes

  1. Tissue oxygenation (TcO2) change from baseline

    Time frame: 120 minutes post-drug-administration

    Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter

  2. Tissue oxygenation (TcO2) change from baseline

    Time frame: 30 (LABA)/40 (LAMA) minutes post-drug administration

    Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter

Secondary outcomes

  1. Slope of Helium (SHe) change from baseline

    Time frame: 120 minutes post-drug administration

    SHe from single-breath washout test (SBWO) assessing peripheral ventilation heterogeneities

  2. Slope of Helium (SHe) change from baseline

    Time frame: 30 (LABA)/40 (LAMA) minutes post-drug administration

    SHe from single-breath washout test (SBWO) assessing peripheral ventilation heterogeneities

  3. Area under reactance curve from 5 Hz (AX) change from baseline

    Time frame: 120 minutes post-drug administration

    AX from forced oscillation test (FOT) evaluating the peripheral lung function

  4. Area under reactance curve from 5 Hz (AX) change from baseline

    Time frame: 30 (LABA)/40 (LAMA) minutes post-drug administration

    AX from forced oscillation test (FOT) evaluating the peripheral lung function

  5. Reactance at 5 Hz (X5) change from baseline

    Time frame: 30 (LABA)/40 (LAMA) minutes post-drug administration

    X5 from forced oscillation test (FOT) also evaluating the peripheral lung function

  6. Resonant frequency (Fres) change from baseline

    Time frame: 120 minutes post-drug administration

    Fres from forced oscillation test (FOT) also evaluating the peripheral lung function

  7. Resonant frequency (Fres) change from baseline

    Time frame: 30 (LABA)/40 (LAMA) minutes post-drug administration

    Fres from forced oscillation test (FOT) also evaluating the peripheral lung function

  8. Peripheral resistance (R5-R19) change from baseline

    Time frame: 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

  9. Peripheral resistance (R5-R19) change from baseline

    Time frame: 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

  10. Lung capillary volume (Vc) change from baseline

    Time frame: 120 minutes post-drug administration

    Vc from single-breath double diffusion technique of nitric oxide (NO) and carbon monoxide (CO) (DLNO/DLCO)

  11. Lung capillary volume (Vc) change from baseline

    Time frame: 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)

  12. Forced Expiratory Volume in 1 Second (FEV1) change from baseline

    Time frame: 120 minutes post-drug administration

    FEV1 from spirometry

  13. Forced Expiratory Volume in 1 Second (FEV1) change from baseline

    Time frame: 30 (LABA)/40 (LAMA) minutes post-drug administration

    FEV1 from spirometry

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Comparison of Bronchodilation and Oxygenation Patterns Induced by Long-acting β2-agonists and Muscarinic Antagonists in Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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