University of Calgary
Calgary, Alberta, T2N4N1, Canada
NCT Number: NCT02989935
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).
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 4
Calgary, Alberta, T2N4N1, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.
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.
Time frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.
Time frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.
University of Calgary
Other
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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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