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

• Sponsor: University of Calgary (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02989935
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 73
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Copd	Procedure: Ventilation; Procedure: Parasternal EMG; Procedure: Phrenic magnetic stimulation	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.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: Apr 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. Minute ventilation change [2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.]

   Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation.

2. Parasternal EMG change [2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.]

   Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.

3. Pressure change with phrenic stimulation [2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.]

   Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada	T2N4N1

Sponsors and Collaborators

• University of Calgary

Investigators

• Principal Investigator: Paul A Easton, MD, PhD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Paul Easton, Assoc.Prof. University of Calgary, University of Calgary
• ClinicalTrials.gov Identifier: NCT02989935
• Other Study ID Numbers: REB16-0147
• First Posted: Dec 12, 2016
• Last Update Posted: Jun 22, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Paul Easton, Assoc.Prof. University of Calgary, University of Calgary: respiratory muscle; bronchodilator

Study Results

No Results Posted as of Jun 22, 2021