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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone vilanterol bronchodilator | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minute ventilation change | Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation. | 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation. |
| Parasternal EMG change | Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle. | 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation. |
| Pressure change with phrenic stimulation | Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves. | 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Easton, MD, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N4N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19820074 | Background | Easton PA, Hawes HG, Doig CJ, Johnson MW, Yokoba M, Wilde ER. Parasternal muscle activity decreases in severe COPD with salmeterol-fluticasone propionate. Chest. 2010 Mar;137(3):558-65. doi: 10.1378/chest.09-0197. Epub 2009 Oct 9. |
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Participant physiologic results and measurements publicly presented.
During 2020 as final results are available.
By researcher contact or inquiry
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D014691 | Ventilation |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.
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| 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. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |