A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma

Activo, no reclutaFase 4ClinicalTrials.gov

ID: NCT06372496Tipo: INTERVENTIONALInicio: 16 de abr de 2024Fin estimado: 22 de ene de 2026

Traducción no disponible, mostrando original

Resumen

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all of the following criteria apply:
Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
Participants who are either:
Currently untreated
Treated with daily maintenance ICS or ICS/LABA
ACQ-6 score ≥1.5 at randomization.
Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2)
Participants must be able to complete the study questionnaires.

Criterios de exclusión

A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
Participants are excluded from the study if any of the following criteria apply:
Recent history of life-threatening asthma
History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
Exposure to inhaler triple therapy \[ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)\] and/or any LAMA-containing therapy within 12 months prior to randomization.
Ongoing need for biologic therapy or recent use of a biologic therapy
Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
Participants with a history of hypersensitivity to any of the study medications

Intervenciones

drug

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Participants will receive FF/UMEC/VI

drug

Inhaled corticosteroids/long-acting beta-2 agonists

Participants will receive ICS/LABA

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Concepción del Uruguay, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Quilmes, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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