Year: 2026
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: -agonist (ICS/LABA) therapy. A previous randomised controlled trial demonstrated clinical benefits of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) single-inhaler triple therapy (SITT) versus FF/VI dual therapy in patients with moderate-severe asthma without a requirement for exacerbation history. Here, we present the protocol for the PERFORM pragmatic trial, comparing the effectiveness of initiating FF/UMEC/VI SITT via the ELLIPTA® inhaler (GSK) versus continuing or initiating non-ELLIPTA ICS/LABA usual care for a broad patient population with uncontrolled asthma. METHODS: PERFORM is a 52-week, stratified, randomised, open-label, active-controlled, parallel-group, global pragmatic trial enrolling adult patients with uncontrolled asthma, currently untreated or treated with ICS or ICS/LABA therapy. Patients will be randomised 1:1 to either initiate once-daily FF/UMEC/VI (intervention) or continue or initiate non-ELLIPTA ICS/LABA (control), receiving treatment in a usual care setting. The primary endpoint is the change from baseline in trough forced expiratory volume in 1 s at week 24. The key secondary endpoint is whether patients achieve improvement (≥ 0.5-point decrease from baseline) in the Asthma Control Questionnaire-7 score at week 24. Other secondary endpoints include clinical remission, health-related quality of life, and work and activity impairment. The trial aims to randomise 1136 patients (568 per arm). PLANNED OUTCOMES: PERFORM is a pragmatic randomised controlled trial generating data relevant to a broad population of patients with uncontrolled asthma representative of routine clinical practice. This trial will also include the first prospective data on clinical remission for patients treated with inhaled therapy.
Source: Pulmonary Therapy
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $7,400
OpenAlex ID: W7128613990