Effects of Acute Long-acting Bronchodilation on Oxygenati... | NCT05927155

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

NCT05927155

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Jul 3, 2023Actual

Enrollment

30Actual

Phase

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

LABA
LAMA

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P2019/239 CCB: B406201939717	Other Identifier	local ethics committee

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2021Actual

Primary Completion Date

Mar 30, 2022Actual

Completion Date

Mar 30, 2022Actual

First Submitted Date

Jun 10, 2023

First Submission Date that Met QC Criteria

Jun 23, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2023

Last Update Posted Date

Jul 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Silvia Perez Bogerd, Chest physician, head of the COPD and Pulmonary Rehabilitation Clinic, Erasme University HospitalPrincipal Investigator

Lead Sponsor

Erasme University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LABA	Drug	Inhalation of 4 puffs of 2,5 µg of a long-acting beta2-agonist (LABA-olodaterol) administered via a spacer device	LABA (olodaterol)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Slope of Helium (SHe) change from baseline	SHe from single-breath washout test (SBWO) assessing peripheral ventilation heterogeneities	120 minutes post-drug administration
Slope of Helium (SHe) change from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Silvia Pérez Bogerd, MD	Erasme University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasme University Hospital		Brussels		1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

When published, the datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C549647	olodaterol
D000069447	Tiotropium Bromide

Ancestor Terms

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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).