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

University of Calgary

Status and phase: Active, not recruiting; Phase 4

Conditions: Copd

Treatments: Procedure: Ventilation; Procedure: Phrenic magnetic stimulation; Procedure: Parasternal EMG

Study type: Interventional

Funder types: Other

Identifiers

NCT02989935

REB16-0147

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Fluticasone vilanterol bronchodilator

Experimental group

Description:

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.

Treatment:

Procedure: Parasternal EMG

Procedure: Phrenic magnetic stimulation

Procedure: Ventilation