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

Study acronym: PERFORM
StatusActive, Not Recruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Results posted: Oct 6, 2026
    • Study completion pushed from Mar 31, 2027 to Jun 14, 2027
    • Interventions: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (Drug), Inhaled corticosteroids/long-acting beta-2 agonists (Drug) to Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (Drug), Inhaled corticosteroids/long-acting beta-2 agonists (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 38 of 38 entries
    • Site details revised at 25 of 117 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary endpoint revised
    • Enrollment target: 1366 to 1358
    • Study completion date: Mar 31, 2027 to Jun 14, 2027
    • Secondary endpoints: 23 to 38
    v7
  3. Enrollment target: 1357 to 1366
    • Study sites: 74 to 117
    • Primary completion date: Sep 8, 2025 to Jul 28, 2025
    • Study completion date: Jan 22, 2026 to Mar 31, 2027
    v6
  4. Enrollment target: 1358 to 1357
    • Primary completion date changed from estimate of Sep 1, 2025 to Sep 8, 2025
    • Study completion date: Mar 11, 2026 to Jan 22, 2026
    v5
  5. Primary completion date: Nov 10, 2025 to Sep 1, 2025
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: 20 to 23
    • Site details revised at 2 of 74 sites
    v4
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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1136 to confirmed 1358
    • Study sites: 69 to 74
    • Primary completion date: Mar 11, 2026 to Nov 10, 2025
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 69 of 69 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
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Asthma
958 trials monitored
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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
Trial Details
NCT Number NCT06372496
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 1,358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov