A study to compare the efficacy,safety and tolerability of FF/UMEC/VI with FF/VI in 12–17-year-olds

• Research type

  Research Study

• Full title

  A Phase 3, 24-week, randomized, double-blind, parallel-group Bayesian Dynamic Borrowing study comparing the efficacy, safety, tolerability, and pharmacokinetics of FF/UMEC/VI with FF/VI in 12-17-year-old participants with inadequately controlled asthma on stable maintenance therapy with ICS/LABA

• IRAS ID

  1007902

• Contact name

  Suki Parry

• Contact email

  sukminder.x.parry@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Clinicaltrials.gov Identifier

  NCT05757102

• Research summary

  This study is being done to assess the effects of the study medicine on lung function and asthma symptoms, to see whether the study medicine is safe and well-tolerated, and to assess, after 24 weeks of treatment, if the study medicine is suitable as maintenance treatment, when compared with the comparator medicine, for children aged 12 to 17 years with asthma.
  About 292 people from approximately 8 countries will take part in this study.
  This study will be divided into 4 periods: a pre-screening period, a screening/run-in period, a treatment period, and a safety follow-up period. The treatment period for this study will last for 24 weeks for each participant and it will take about 31 weeks to complete all 4 periods of the study.
  The study medicine is a GSK medicine given to treat asthma in adults 18 years of age or older. It is a combination of the following 3 medicines in a single Ellipta inhaler: fluticasone furoate[FF]/umeclidinium bromide[UMEC]/vilanterol trifenatate [VI]. The study medicine has been approved for use in adults in several countries under the brand name Trelegy Ellipta.
  The study medicine will be compared with the effectiveness and safety of a dual therapy medicine. This dual therapy is a combination of FF and VI in a single Ellipta inhaler. We shall refer to the dual therapy medicine as the comparator medicine. The comparator medicine is marketed for the treatment of asthma.
  All study participants will be divided into 2 treatment groups (i.e. either the study medicine treatment group or the comparator medicine treatment group).
  The effects of the study medicine, both good and bad, will be compared to the comparator medicine.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  23/ES/0029

• Date of REC Opinion

  6 Sep 2023

• REC opinion

  Further Information Favourable Opinion