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Pulmonary Disease, Chronic ObstructivePhase 3NCT05927155

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

A Phase 3 study testing LABA and LAMA in people with Pulmonary Disease, Chronic Obstructive, run by Erasme University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
LABA and LAMA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBelgium
Study dates
15 Jun 2021to 30 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD diagnosis according to international criteria

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Belgium1 site

  • Erasme University Hospital

    Brussels, 1070

Other trials in Belgium

About this study

Official title: Comparison of Bronchodilation and Oxygenation Patterns Induced by Long-acting β2-agonists and Muscarinic Antagonists in Chronic Obstructive Pulmonary Disease (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.

Read the 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.

Being tested
LABA, LAMA
Keywords
long-acting ß2-agonist, long-acting muscarinic antagonist, gas exchange, oxygen, small airways, lung capillary volume
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LABADrug

    Also called Olodaterol, Striverdi Respimat

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

  • LAMADrug

    Also called Tiotropium, Spiriva Respimat

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

Study groups in NCT05927155
Study groupRoleWhat they receive
LABA (olodaterol)ExperimentalAfter 4-5 days washout period, during the first visit, participants received a long-acting beta2-agonist (LABA)
Receives: Drug: LABA
LAMA (tiotropium)ExperimentalTwo days after the first visit, during the second visit , participants received a long-acting muscarinic antagonist (LAMA)
Receives: Drug: LAMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tissue oxygenation (TcO2) change from baseline

    Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter

    Measured: 120 minutes post-drug-administration

  2. Tissue oxygenation (TcO2) change from baseline

    Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter

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

Secondary outcomes (13)

  1. Slope of Helium (SHe) change from baseline

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

    Measured: 120 minutes post-drug administration

  2. Slope of Helium (SHe) change from baseline

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

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

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

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

    Measured: 120 minutes post-drug administration

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

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

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

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

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

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

  6. Resonant frequency (Fres) change from baseline

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

    Measured: 120 minutes post-drug administration

  7. Resonant frequency (Fres) change from baseline

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

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

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

    Peripheral resistance, assessed as frequency dependence of resistance (R5-R19) from forced oscillation test (FOT) also evaluating the peripheral lung function

    Measured: 120 minutes post-drug administration

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

    Peripheral resistance, assessed as frequency dependence of resistance (R5-R19) from forced oscillation test (FOT) also evaluating the peripheral lung function

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

  10. Lung capillary volume (Vc) change from baseline

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

    Measured: 120 minutes post-drug administration

  11. Lung capillary volume (Vc) change from baseline

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

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

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

    FEV1 from spirometry

    Measured: 120 minutes post-drug administration

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

    FEV1 from spirometry

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start15 Jun 2021
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
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).
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927155
Sponsor's protocol ID
SRB-201903-052
Other IDs
P2019/239 CCB: B406201939717
Status last verified
Jun 2023
First submitted
10 Jun 2023
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: When published, the datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LABA and LAMA in people with Pulmonary Disease, Chronic Obstructive, run by Erasme University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tissue oxygenation (TcO2) change from baseline (time frame: 120 minutes post-drug-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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