RELVAR for COPD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Calgary

Must be taking: Long acting bronchodilators

Disqualifiers: Hypersensitivity, Angina, Cardiovascular risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new inhaler medicine combination affects breathing muscles and lung function in individuals with severe bronchitis or emphysema, both forms of COPD (Chronic Obstructive Pulmonary Disease). The treatment being tested combines two drugs, fluticasone furoate and vilanterol trifenatate, which help open airways and ease breathing. This study targets individuals with stable, severe COPD who regularly use long-acting inhalers. As a Phase 4 trial, the research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires participants to be on long-acting bronchodilator therapy. It's best to discuss your current medications with the trial team.

What is the safety track record for fluticasone furoate and vilanterol trifenatate?

Research has shown that the combination of fluticasone furoate and vilanterol trifenatate is generally well-tolerated by people with COPD, a lung disease that makes breathing difficult. Studies have found that this treatment reduces the number of flare-ups without causing serious heart-related side effects or increasing death rates.

Although some concerns exist about side effects in children, these do not apply to adults with severe bronchitis or emphysema. Overall, evidence suggests that the treatment is safe for adults and can improve lung function and overall health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard COPD treatments that primarily involve single-agent bronchodilators or inhaled corticosteroids, the fluticasone furoate and vilanterol trifenatate combination offers a dual-action approach. This treatment combines a long-acting beta-agonist (LABA) with an inhaled corticosteroid, working synergistically to both open the airways and reduce inflammation. Researchers are excited because this combination can potentially enhance lung function more effectively, offering faster and more sustained relief for COPD patients compared to using either component alone. Additionally, the delivery through a standard dry powder inhaler makes administration straightforward and patient-friendly.

What is the effectiveness track record for fluticasone furoate/vilanterol trifenatate in treating COPD?

Research shows that using fluticasone furoate and vilanterol trifenatate together can help people with COPD breathe better. Studies have found that this treatment reduces symptoms like shortness of breath and improves lung function. Compared to other similar treatments, patients using this combination achieved better results. The treatment is convenient, requiring only once-daily use with an inhaler. This combination is already approved for treating COPD, proving its effectiveness for this condition. ^{1 3 5 6 7}

Who Is on the Research Team?

Paul A Easton, MD, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inhalation of fluticasone furoate/vilanterol trifenatate, 100 mcg/25 mcg combination, using a standard dry powder inhaler

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in minute ventilation, parasternal EMG, and pressure with phrenic stimulation after treatment

2 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fluticasone Furoate
• Vilanterol Trifenatate

Trial Overview

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.

How Is the Trial Designed?

Group I: Fluticasone vilanterol bronchodilator Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

In a 6-year observational study involving 3426 patients with asthma and/or COPD, fluticasone furoate/vilanterol (FF/VI) demonstrated a good safety profile, with an overall adverse event rate of 30.9% and serious adverse events occurring in only 4.1% of patients.

FF/VI was effective in improving lung function, with significant increases in forced expiratory volume in 1 second (FEV1) observed in patients with asthma (0.09 L), COPD (0.11 L), and those with both conditions (0.05 L), indicating its efficacy in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea. Cho, EY., Cho, JE., Jang, SH., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24114969/

A comparison of the efficacy and safety of once-daily ...

We compared the efficacy and safety of FF/VI versus fluticasone propionate/salmeterol (FP/SAL) twice daily over 12 weeks. Moderate to very severe COPD patients ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5933662/

The combination of fluticasone furoate and vilanterol ...

This paper reviews the literature supporting the use of the once-daily, combined dry powder inhaler fluticasone furoate (FF) and vilanterol trifenatate (VI) in ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04671355

TRIMBOW® and RELVAR® on Lung Stiffness Reduction ...

A Phase IV, Open Label, Multicentre, Randomised, 2-way Cross-over Exploratory Clinical Trial Comparing TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on Lung Stiffness ...

4.

bmjopen.bmj.com

bmjopen.bmj.com/content/2/1/e000370

Efficacy and safety of 4 weeks' treatment with combined ...

Given the 4-week duration of this study, there was no end point or surrogate marker to specifically address the relative clinical effects of FF in COPD (such as ...

5.

publications.ersnet.org

publications.ersnet.org/content/erj/43/3/763

A comparison of the efficacy and safety of once-daily ...

We compared the efficacy and safety of FF/VI versus fluticasone propionate/salmeterol (FP/SAL) twice daily over 12 weeks.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27864038/

A systematic review with meta-analysis of fluticasone ...

Conclusions: FF/VI combination was associated with a decrease of the rate of COPD exacerbations, without affecting mortality or cardiovascular outcomes in ...

7.

fda.gov

fda.gov/media/169200/download

Breo Ellipta (fluticasone furoate/vilanterol trifenatate)

This review focuses on U.S. serious unlabeled adverse events associated with fluticasone furoate/vilanterol trifenatate in pediatric patients.