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

NCT05927155 | Completed Phase 3

• 2 other identifiers: SRB-201903-052P2019/239 CCB: B406201939717
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

long-acting ß2-agonist; long-acting muscarinic antagonist; gas exchange; oxygen; small airways; lung capillary volume

Outcome Measures

Primary Outcomes (2)

• Tissue oxygenation (TcO2) change from baseline

  Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter

  120 minutes post-drug-administration

• Tissue oxygenation (TcO2) change from baseline

  Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter

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

Secondary Outcomes (13)

• Slope of Helium (SHe) change from baseline

  120 minutes post-drug administration

• Slope of Helium (SHe) change from baseline

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

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

  120 minutes post-drug administration

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

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

• Reactance at 5 Hz (X5) change from baseline

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

Study Arms (2)

LABA (olodaterol)

EXPERIMENTAL

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

Drug: LABA

LAMA (tiotropium)

EXPERIMENTAL

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

Drug: LAMA

Interventions

LABA DRUG

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

Also known as: Olodaterol, Striverdi Respimat

LABA (olodaterol)

LAMA DRUG

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

Also known as: Tiotropium, Spiriva Respimat

LAMA (tiotropium)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnosis according to international criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Silvia Pérez Bogerd, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chest physician, head of the COPD and Pulmonary Rehabilitation Clinic

Model Details: 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).

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: July 3, 2023
• Study Start: June 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the publication of the results
• Access Criteria: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

Locations

BE (1)