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Active, Not Recruiting

NCT Number: NCT02989935

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Calgary

Calgary, Alberta, T2N4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilation

Procedure

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

Procedure

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

Procedure

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

Primary outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2016
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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