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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Paul Easton, University of Calgary
ClinicalTrials.gov Identifier:
NCT02989935
First received: December 1, 2016
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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).

Condition Intervention Phase
Copd
Procedure: Ventilation
Procedure: Parasternal EMG
Procedure: Phrenic magnetic stimulation
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: April 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Procedure: Ventilation
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02989935

Contacts
Contact: Paul A Easton, MD, PhD 403-220-7045 peaston@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N4N1
Contact: Paul A Easton, MD, PhD    403-220-7045    peaston@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Paul A Easton, MD, PhD University of Calgary
  More Information

Publications:
Responsible Party: Paul Easton, Assoc.Prof. University of Calgary, University of Calgary
ClinicalTrials.gov Identifier: NCT02989935     History of Changes
Other Study ID Numbers: REB16-0147
Study First Received: December 1, 2016
Last Updated: December 7, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Calgary:
respiratory muscle
bronchodilator

Additional relevant MeSH terms:
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on March 24, 2017