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

NCT02989935 | Active Not Recruiting Phase 4

• 1 other identifier: REB16-0147
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Copd

Keywords

respiratory muscle; bronchodilator

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

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.

Procedure: Ventilation; Procedure: Parasternal EMG; Procedure: Phrenic magnetic stimulation

Interventions

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.

Fluticasone vilanterol bronchodilator

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.

Fluticasone vilanterol bronchodilator

Phrenic magnetic stimulation PROCEDURE

Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.

Fluticasone vilanterol bronchodilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 19820074 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Paul A Easton, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. University of Calgary

Model Details: Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 12, 2016
• Study Start: April 1, 2016
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: During 2020 as final results are available.
• Access Criteria: By researcher contact or inquiry

Locations

CA (1)