A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Enrollment reduced 53% 292 → 138 participants
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Record History

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  1. Enrollment reduced: 292 → 138 participants Show 5 more changesShow less
    • Study completion date: Jan 29, 2027 to Jan 28, 2027
    • Interventions: ELLIPTA (Device), FF/UMEC/VI (Drug), FF/VI (Drug) to ELLIPTA (Device), FF/UMEC/VI (Drug), FF/VI (Drug)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised at 1 of 67 sites
  2. Trial sites expanded: 62 → 67 locations
    • Primary completion date: Jan 22, 2027 to Jan 26, 2027
    • Study completion date: Jan 28, 2027 to Jan 29, 2027
    • Start date: Apr 25, 2023 to Apr 24, 2023
    v9
  3. Study sites: 42 to 62
    • Primary completion date: Jan 15, 2027 to Jan 22, 2027
    • Study completion date: Jan 15, 2027 to Jan 28, 2027
    v8
  4. Study sites: 35 to 42
    • Start date: Apr 24, 2023 to Apr 25, 2023
    v7
  5. Study sites: 32 to 35v6
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  1. Study sites: 81 to 32v5
  2. Primary and study completion dates: Nov 18, 2024 to Jan 15, 2027
    • Study sites: 16 to 81
    v4
  3. Primary and study completion dates: Oct 10, 2024 to Nov 18, 2024v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 16
    • Start date changed from estimate of Mar 16, 2023 to Apr 24, 2023
    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
See 20 trials at risk
Asthma
958 trials monitored
See 36 trials at risk
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Trial Details
NCT Number NCT05757102
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov