RELVAR for COPD

Recruiting in Palo Alto (17 mi)

Overseen byPaul A Easton, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults with severe COPD who can handle a minor surgery with sedation, take their meds regularly, and are able to walk. They should be on long-term bronchodilator therapy but not have had a major flare-up in the last 2 months or serious heart issues.

Inclusion Criteria

Compliant with use of prescribed medications

I am healthy enough for a minor surgery with sedation.

I am on medication to help open my airways.

+1 more

Exclusion Criteria

You are allergic to the combination of fluticasone furoate and vilanterol.

You are allergic to milk proteins.

I have chest pain or a high risk for heart problems.

+2 more

Participant Groups

The study tests how fluticasone furoate/vilanterol (a long-acting inhaler medication) affects breathing muscles and overall ventilation in people with severe chronic bronchitis or emphysema, which are forms of COPD.

1Treatment groups

Experimental Treatment

Group I: Fluticasone vilanterol bronchodilatorExperimental Treatment3 Interventions

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.