RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD

February 17, 2025 updated by: Paul Easton, University of Calgary
This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In adults with severe, minimally reversible bronchitis or emphysema (COPD), there is progressive hyperinflation of the lungs with associated flattening and inefficiency of the major respiratory muscle, the diaphragm. These changes limit physical activity and exercise, and provoke shortness of breath - dyspnea.

These debilitating symptoms are often significantly lessened with ultra long acting combination bronchodilators, even in adults where the bronchodilator does not produce any measurable improvement in either airflow or lung hyperinflation.

This symptomatic improvement in adults with severe, minimally reversible COPD may occur because of a direct benefit of the bronchodilator on respiratory muscles and ventilation.

This study examines the effect of the ultra long acting bronchodilator fluticasone furoate/vilanterol trifenatate upon the upper anterior chest wall respiratory muscles (parasternals), the diaphragm, and breathing pattern.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N1
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ambulatory, stable severe COPD (GOLD Class III-IV)
  • on long acting bronchodilator therapy
  • compliant with use of prescribed medications
  • fit for minor surgical procedure including intravenous sedation

Exclusion Criteria:

  • hypersensitivity to milk proteins
  • hypersensitive to fluticasone furoate/vilanterol formulation
  • angina or substantial cardiovascular risk
  • exacerbation of COPD within the preceding 2 months
  • significant non-respiratory system disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluticasone vilanterol bronchodilator

Inhalation of fluticasone furoate/vilanterol trifenatate, 100 mcg/25 mcg combination, bronchodilator,using standard dry powder inhaler.

Interventions include ventilation, parasternal EMG, and phrenic magnetic stimulation.
Procedure: Ventilation
Measurements of ventilation with subjects seated, and breathing across a pneumotachygraph and pressure transducer to measure inspiratory airflow, during both resting and CO2 stimulated breathing.
Procedure: Parasternal EMG
Recordings of electrical activity (EMG) from the parasternal intercostal muscle in the second intercostal space on the upper anterior chest wall adjacent to the sternum.
Procedure: Phrenic magnetic stimulation
Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minute ventilation change
Time Frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation.
2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Parasternal EMG change
Time Frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.
2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Pressure change with phrenic stimulation
Time Frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.
2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Paul A Easton, MD, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimated)

December 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB16-0147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant physiologic results and measurements publicly presented.

IPD Sharing Time Frame

During 2020 as final results are available.

IPD Sharing Access Criteria

By researcher contact or inquiry

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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