RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02989935|
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Copd||Procedure: Ventilation Procedure: Parasternal EMG Procedure: Phrenic magnetic stimulation||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: 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.
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.
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.
Procedure: Phrenic magnetic stimulation
Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989935
|Contact: Paul A Easton, MD, PhDemail@example.com|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N4N1|
|Contact: Paul A Easton, MD, PhD 403-220-7045 firstname.lastname@example.org|
|Principal Investigator:||Paul A Easton, MD, PhD||University of Calgary|