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

Phase 4

Active, not recruiting

• Conditions: Copd
• Interventions: Procedure: Ventilation; Procedure: Parasternal EMG; Procedure: Phrenic magnetic stimulation

• Registration Number: NCT02989935
• Lead Sponsor: University of Calgary

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-03-31
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluticasone vilanterol bronchodilator	Ventilation	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.
Fluticasone vilanterol bronchodilator	Phrenic magnetic stimulation	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.
Fluticasone vilanterol bronchodilator	Parasternal EMG	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.

Primary Outcome Measures

Name	Time	Method
Parasternal EMG change	2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.	Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.
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.
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.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada