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

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02989935
• Other study ID #: REB16-0147
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: July 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Copd

Intervention

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Parasternal EMG change	Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.	2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Primary	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.