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Corticosteroid

RELVAR for COPD

Phase 4

Waitlist Available

Led By Paul A Easton, MD, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On long acting bronchodilator therapy

Ambulatory, stable severe COPD (GOLD Class III-IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

Awards & highlights

Study Summary

This trial studies effects of a drug combo to reduce breathing problems in adults with COPD.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects may include reactions related to inhaling the medication such as throat irritation, hoarseness, thrush infections in the mouth, headaches, and increased risk of pneumonia especially in patients with COPD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on medication to help open my airways.

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I have severe COPD but can still walk around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Minute ventilation change

Parasternal EMG change

Pressure change with phrenic stimulation

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ventilation

2021

Completed Phase 2

~320

0 / 2Eligibility criteria met