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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02989935

Enrollment

Registered

2016-12-12

Start date

2016-04-30

Completion date

2026-07-01

Last updated

2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

Keywords

respiratory muscle, bronchodilator

Brief summary

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).

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.

Interventions

PROCEDUREVentilation

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.

PROCEDUREParasternal 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.

PROCEDUREPhrenic magnetic stimulation

Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026