RELVAR for COPD
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.12345Why 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.13567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inhalation of fluticasone furoate/vilanterol trifenatate, 100 mcg/25 mcg combination, using a standard dry powder inhaler
Follow-up
Participants are monitored for changes in minute ventilation, parasternal EMG, and pressure with phrenic stimulation after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fluticasone Furoate
- Vilanterol Trifenatate
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor