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Vilanterol

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.

Table of Contents

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.[1][2][3][4][5] The studies are interventional, meaning researchers give a treatment and compare results between groups.[1][2][3][4][5]

Across these trials, the main conditions are chronic obstructive pulmonary disease (COPD) and asthma.[1][2][3][4][5] One study also includes COPD with heart failure and reduced ventricular ejection fraction, which means the heart is pumping less strongly than normal.[3]

COPD studies

One completed trial, the ANTES B+ study, compared triple therapy with LABA-LAMA combination treatment in high-risk GOLD B COPD patients.[1] Its goal was to see whether more patients could stay clinically controlled at all study visits over 12 months.[1] The study enrolled 1,028 people, making it the largest trial in this set.[1]

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.[5] A blood eosinophil count is a lab test that measures a type of white blood cell and can help describe inflammation patterns.[5]

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%.[3] It aimed to see whether treatment improved stroke volume during exercise, which is the amount of blood the heart pumps with each beat.[3]

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One withdrawn Phase 3 trial studied adult participants with asthma and compared fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg with BREO ELLIPTA 100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.[2] The study aimed to show therapeutic equivalence between the generic product and the branded product, and also to show superiority over placebo.[2]

The SECURE study also involved asthma, but it focused on symptom control and treatment adherence, which means how well people follow the treatment plan.[4] It compared different device-based treatment groups and measured asthma control after 6 months using the ACT score, a questionnaire for asthma control.[4]

Participants and comparators

These trials mainly include adults, but each study targets a specific patient group.[1][2][3][4][5] Some studies focus on COPD patients with high risk or additional heart disease, while others focus on adults with asthma.[1][2][3][4][5]

The comparison treatments include placebo, LABA-LAMA combinations, triple therapy, and other inhaled products.[1][2][3][5] In the asthma equivalence study, the trial compared a Vilanterol-containing inhalation powder with BREO ELLIPTA and placebo.[2]

Outcomes measured

The main outcomes in these studies include clinical control, health status, lung function, and exercise-related measures.[1][2][3][5] 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.[1][5]

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.[2] The COPD and heart failure study used exercise Doppler-echocardiography and cardiopulmonary exercise testing to measure heart and breathing response during exercise.[3]

Trial status and size

The trial statuses are mixed: three studies are completed, one is authorised, and one was withdrawn.[1][2][3][4][5] 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.[2][3][1]

Trial ID Phase Condition studied Status Enrollment
2023-507304-32-00 Phase 3 Chronic Obstructive Pulmonary Disease Completed 1028
2025-521565-27-00 Phase 3 Asthma Withdrawn 1430
2024-519513-61-00 Phase 3 COPD with heart failure Authorised 60
NCT05626777 Phase 3 Asthma Completed 130
2023-508300-37-00 Phase 3 COPD Completed 316

FAQ

  • What conditions are being studied in Vilanterol trials? The trials in this set study asthma and chronic obstructive pulmonary disease (COPD). One trial also includes COPD patients who have heart failure.
  • Who can take part in these trials? The target groups are mainly adults with asthma or COPD. Some studies focus on specific groups, such as high-risk GOLD B COPD patients, people with asthma, or COPD patients with heart failure and reduced heart pumping function.
  • What phases are the Vilanterol trials? All trials listed here are Phase 3 studies. Phase 3 means the treatment is tested in larger groups to compare how well it works and how safe it is.
  • What are the trials trying to measure? The studies measure outcomes such as clinical control, health status, lung function, exercise response, and treatment equivalence. Some trials use questionnaires or lung tests, while others look at exercise-related heart and lung measures.
  • Are all the trials completed? No. Some trials are completed, one is authorised, and one was withdrawn. This means the research status is different across studies.

Ongoing Clinical Trials on Vilanterol

  • Study on the Effects of Umeclidinium and Vilanterol in Patients with COPD and Heart Failure

    Recruiting

    3 1 1
    Investigated drugs:
    Spain

  • Study comparing fluticasone furoate and vilanterol inhalation powder with BREO ELLIPTA in adults with asthma to evaluate their therapeutic equivalence and safety

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on the Effectiveness of Beclometasone, Glycopyrronium, and Formoterol in COPD Patients with Asthma Characteristics

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing Trelegy with LABA-LAMA Drug Combination for Improving COPD Control in High-Risk Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Asthma Control and Adherence with Mepolizumab in Pre-filled Devices for Patients with Asthma

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Asthma: A long-term lung disease that can cause wheezing, shortness of breath, chest tightness, and coughing.
  • Chronic Obstructive Pulmonary Disease (COPD): A long-term lung disease that makes it hard to breathe. It includes conditions that limit airflow, often because the airways are narrowed.
  • Phase 3: A late stage of clinical research where a treatment is tested in larger groups of people to see how well it works and to compare it with other treatments.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare outcomes.
  • Placebo: A look-alike treatment with no active medicine, used to compare results fairly.
  • Clinical control: A measure of how well a disease is kept under control. In these trials, it is assessed using set criteria or questionnaires.
  • Health status: How a person feels and functions because of their disease, often measured with a questionnaire.
  • FEV1: A lung test result that shows how much air a person can blow out in one second.
  • AUC0-24h: A way to measure the total effect of a test result over 24 hours.
  • Bioequivalence: A comparison to see whether two treatments act in a similar way in the body or give similar clinical effects.
  • Triple therapy: A treatment plan that uses three medicines together.
  • LABA/LAMA: A combination of two types of inhaled bronchodilators, meaning medicines that help open the airways.

References

  1. https://clinicaltrials.gov/study/2023-507304-32-00
  2. https://clinicaltrials.gov/study/2025-521565-27-00
  3. https://clinicaltrials.gov/study/2024-519513-61-00
  4. https://clinicaltrials.eu/trial/study-on-asthma-control-and-adherence-with-mepolizumab-in-pre-filled-devices-for-patients-with-asthma/
  5. https://clinicaltrials.gov/study/2023-508300-37-00