NCT06372496Active, not recruitingPhase 4
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1358 (actual)
- First submitted
- 15 Apr 2024
- Start date
- 16 Apr 2024
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Asthma
- NCT number
- NCT06372496
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1358
- From 16 Apr 2024 to the primary completion date, 28 Jul 2025
- 89 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
- A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
- 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 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.
Other illness
- Recent history of life-threatening asthma
- Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
- Participants with a history of hypersensitivity to any of the study medications
Other
- Participants are excluded from the study if any of the following criteria apply:
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.