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

NCT02989935 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Calgary

Phase

Phase 4

Started

2016-04

Last updated

2025-02-18

Condition(s) studied

Copd

Investigational drug(s) / intervention(s)

VentilationParasternal EMGPhrenic magnetic stimulation

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.

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.

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

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
University of Calgary	Calgary	Alberta

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02989935 on ClinicalTrials.gov ↗ ← All trials in Canada