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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug RELVAR for COPD?

Research shows that the drug RELVAR, which combines fluticasone furoate and vilanterol, improves lung function and reduces flare-ups in people with COPD. It is generally well tolerated and offers the convenience of once-daily use, which may help patients stick to their treatment plan. ^{1 2 3 4 5}

Is RELVAR safe for humans?

RELVAR, also known as Fluticasone Furoate/Vilanterol, has been generally well tolerated in studies for COPD and asthma, but there is an increased risk of pneumonia with long-term use. ^{1 3 4 6 7}

How is the drug Fluticasone Furoate/Vilanterol unique for treating COPD?

Fluticasone Furoate/Vilanterol is unique because it combines a corticosteroid with a long-acting bronchodilator in a once-daily inhaler, which can improve lung function and reduce flare-ups more effectively than some other treatments. Its once-daily dosing may also help patients stick to their treatment plan better. ^{1 3 4 8 9}

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).

Research Team

Paul A Easton, MD, PhD

Principal Investigator

University of Calgary

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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Fluticasone furoate/vilanterol: a review of its use in chronic obstructive pulmonary disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review with meta-analysis of fluticasone furoate/vilanterol combination for the treatment of stable COPD. [2018]

3. New Zealand 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Combination of fluticasone furoate and vilanterol for the treatment of chronic obstructive pulmonary disease. [2014]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of fluticasone furoate/vilanterol in exercising asthmatic adolescents: A randomized and open label trial. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Fluticasone furoate/vilanterol: a review of its use in patients with asthma. [2018]