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

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 4

Conditions: Asthma

Treatments: Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate; Drug: Inhaled corticosteroids/long-acting beta-2 agonists

Study type: Interventional

Funder types: Industry

Identifiers

NCT06372496

219912

Details and patient eligibility

About

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

Enrollment: 1,358 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,358 participants in 2 patient groups

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI)

Experimental group

Treatment:

Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA)

Active Comparator group

Treatment:

Drug: Inhaled corticosteroids/long-acting beta-2 agonists