A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Launched by GLAXOSMITHKLINE · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for asthma in young people aged 12 to 17. The main goal is to see how well a combination medicine called Fluticasone Furoate, Umeclidinium, and Vilanterol (FF/UMEC/VI) works in improving lung function compared to another treatment made up of Fluticasone Furoate and Vilanterol (FF/VI) over 24 weeks. Participants will be closely monitored to ensure their safety and how well they tolerate the medication.

To join the study, participants must have been diagnosed with asthma for at least a year and have been using certain asthma medications daily for the past 12 weeks. They should also be experiencing symptoms that aren't fully controlled despite their current treatment. The trial is currently recruiting, and it's important for potential participants to know that they will be asked about their asthma history and current condition before being enrolled. This study aims to help find better treatments for asthma, which could greatly benefit young patients.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
• • Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0.
• • Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of \>250 to \<=500 microgram (mcg)/day fluticasone propionate, or equivalent).
• • In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
• • Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
• • A best pre-bronchodilator FEV1 \>40% to \<=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.
• Exclusion Criteria:
• • Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
• • Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
• • History of Life-threatening Asthma
• • Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
• • Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.