RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Copd
- Sponsor
- University of Calgary
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Parasternal EMG change
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Paul Easton
Assoc.Prof. University of Calgary
University of Calgary
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.