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Clinical Trials in China / NCT06372496
Active, not recruiting Phase 4

Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

NCT06372496 · tracked via the Priya Life Science China tracker
Sponsor
GlaxoSmithKline
Phase
Phase 4
Started
2024-04-16
Last updated
2026-03-24

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatateInhaled corticosteroids/long-acting beta-2 agonists

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate: Participants will receive FF/UMEC/VI

Inhaled corticosteroids/long-acting beta-2 agonists: Participants will receive ICS/LABA

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization. 2. Participants who are either: * Currently untreated * Treated with daily maintenance ICS or ICS/LABA 3. ACQ-6 score ≥1.5 at randomization. 4. 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) 5. Participants must be able to complete the study questionnaires. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Recent history of life-threatening asthma 2. History of \>1 severe exacerbation of asthma within 12 months prior to randomization. 3. 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. 4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization. 5. 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. 6. Ongoing need for biologic therapy or recent use of a biologic therapy 7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines. 8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study. 9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing 10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization. 11. Participants with a history of hypersensitivity to any of the study medications

Primary outcome measure(s)

Trial sites (117)

FacilityCityRegionStatus
GSK Investigational Site Centreville Alabama
GSK Investigational Site Little Rock Arkansas
GSK Investigational Site Newport Beach California
GSK Investigational Site Newark Delaware
GSK Investigational Site Clearwater Florida
GSK Investigational Site Florida City Florida
GSK Investigational Site Miami Florida
GSK Investigational Site Miami Florida
GSK Investigational Site Miami Florida
GSK Investigational Site Miami Florida
GSK Investigational Site North Miami Beach Florida
GSK Investigational Site Palm Springs Florida
GSK Investigational Site Port Charlotte Florida
GSK Investigational Site Tallahassee Florida
GSK Investigational Site Normal Illinois
GSK Investigational Site New Orleans Louisiana
GSK Investigational Site Bangor Maine
GSK Investigational Site Detroit Michigan
GSK Investigational Site Warren Michigan
GSK Investigational Site Missoula Montana
GSK Investigational Site Papillion Nebraska
GSK Investigational Site Brick New Jersey
GSK Investigational Site Linwood New Jersey
GSK Investigational Site New Windsor New York
GSK Investigational Site Asheville North Carolina
GSK Investigational Site Charlotte North Carolina
GSK Investigational Site Greenville North Carolina
GSK Investigational Site Winston-Salem North Carolina
GSK Investigational Site Cincinnati Ohio
GSK Investigational Site Philadelphia Pennsylvania
GSK Investigational Site Pittsburgh Pennsylvania
GSK Investigational Site Rock Hill South Carolina
GSK Investigational Site Spartanburg South Carolina
GSK Investigational Site Beaumont Texas
GSK Investigational Site Dallas Texas
GSK Investigational Site Bellingham Washington
GSK Investigational Site Buenos Aires Argentina
GSK Investigational Site Buenos Aires Argentina
GSK Investigational Site Buenos Aires Argentina
GSK Investigational Site Buenos Aires Argentina

+ 77 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06372496 on ClinicalTrials.gov ↗ ← All trials in China