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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2026-07-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Copd

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ventilation

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Phrenic magnetic stimulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No