Clinical trial NCT02989935: RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
Official title: RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Copd
Keywords: respiratory muscle
bronchodilator
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Minute ventilation change
timeFrame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
measure: Parasternal EMG change
timeFrame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
measure: Pressure change with phrenic stimulation
timeFrame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Paul A Easton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.