In short
Clinical trials investigating Vilanterol are studying how it performs in people with asthma and chronic obstructive pulmonary disease (COPD). These studies look at treatment benefit, safety, and patient-reported control, often in adults with moderate to high disease burden. Some trials also compare Vilanterol-containing treatments with placebo or other inhaled therapies.
Key points
- Clinical trials investigating Vilanterol are mainly focused on asthma and COPD, with one study also looking at COPD patients who have heart failure. All of the listed studies are Phase 3 trials, so they are designed to compare how well treatments work in larger patient groups. The trials include adults with different levels of disease severity, such as high-risk COPD patients and people with asthma. Some studies compare Vilanterol-containing treatments with placebo, while others compare them with other inhaled treatments. The main outcomes include clinical control, health status, lung function, and exercise-related measures. Trial status varies across the studies, including completed, authorised, and withdrawn.
Trial overview
The trials listed here are studying Vilanterol in Phase 3 research, which is a late stage of testing in larger groups of patients. The studies are interventional, meaning researchers give a treatment and compare results between groups.
Across these trials, the main conditions are chronic obstructive pulmonary disease (COPD) and asthma. One study also includes COPD with heart failure and reduced ventricular ejection fraction, which means the heart is pumping less strongly than normal.
COPD studies
One completed trial, the ANTES B+ study, compared triple therapy with LABA-LAMA combination treatment in high-risk GOLD B COPD patients. Its goal was to see whether more patients could stay clinically controlled at all study visits over 12 months. The study enrolled 1,028 people, making it the largest trial in this set.
The TRACkER trial also studied COPD in a primary care population, but it focused on a different question: whether triple therapy improved health status more than LABA/LAMA treatment in symptomatic, inhaled-corticosteroid-naive patients with asthma-like features and blood eosinophils of at least 100 cells per microliter. A blood eosinophil count is a lab test that measures a type of white blood cell and can help describe inflammation patterns.
The authorised study on dual bronchodilation with umeclidinium/vilanterol looked at COPD patients who also had heart failure with an ejection fraction between 35% and 50%. It aimed to see whether treatment improved stroke volume during exercise, which is the amount of blood the heart pumps with each beat.
Asthma studies
One withdrawn Phase 3 trial studied adult participants with asthma and compared fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg with BREO ELLIPTA 100 mcg/25 mcg and placebo. The study aimed to show therapeutic equivalence between the generic product and the branded product, and also to show superiority over placebo.
The SECURE study also involved asthma, but it focused on symptom control and treatment adherence, which means how well people follow the treatment plan. It compared different device-based treatment groups and measured asthma control after 6 months using the ACT score, a questionnaire for asthma control.
Participants and comparators
These trials mainly include adults, but each study targets a specific patient group. Some studies focus on COPD patients with high risk or additional heart disease, while others focus on adults with asthma.
The comparison treatments include placebo, LABA-LAMA combinations, triple therapy, and other inhaled products. In the asthma equivalence study, the trial compared a Vilanterol-containing inhalation powder with BREO ELLIPTA and placebo.
Outcomes measured
The main outcomes in these studies include clinical control, health status, lung function, and exercise-related measures. Clinical control was measured as being controlled at all study visits in one COPD trial, and as a change in the Clinical COPD Questionnaire in another.
The asthma bioequivalence study used FEV1, which is the amount of air a person can blow out in one second, including a 24-hour measure called AUC0-24h and a morning pre-dose measure after 4 weeks. The COPD and heart failure study used exercise Doppler-echocardiography and cardiopulmonary exercise testing to measure heart and breathing response during exercise.
Trial status and size
The trial statuses are mixed: three studies are completed, one is authorised, and one was withdrawn. Enrollment ranges from 60 participants in the smallest study to 1,430 in the largest, showing that the research questions vary from focused clinical testing to larger comparative studies.