Real-world use of Breztri/Trixeo for the management of COPD in a UK primary care population

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Budesonide/glycopyrrolate/formoterol; BREZTRI/TRIXEO
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL11) formoterol, glycopyrronium bromide and budesonide

  formoterol, glycopyrronium bromide and budesonide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients with a recorded diagnostic COPD code who started budesonide/glycopyrrolate/formoterol (BGF) with ≥ 2 prescriptions within 90-days were identified in the UK Optimum Patient Care Research Database and followed from first prescription until censoring at the end of follow-up (180-days), death, leaving database or end of data at 24/10/2022.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  750

Study design details

• Study design:
  Historical cohort study
• Main study objective:
  To describe the acceptability and clinical outcomes of Breztri/Trixeo amongst patients with COPD.
• Setting:
  UK Optimum Patient Care Research Database
• Comparators:
  N/A
• Outcomes:
  The primary outcome will be medication success assessed at 90 days (early medication success) after Breztri/Trixeo initiation, which will be as no major cardiac and respiratory events (MACRE) and no pneumonia, 1. patient demographic and clinical characteristics at initiation, 2. changes in CAT score, 3. factors associated with the primary outcome CAT change at 90 days, 4. medication success assessed at 180 days, 5. short-acting beta-agonist use, 6. acceptability of medication change, 7. adherence, 8. overall number of inhalers used, 9. change in COPD control and in exercise capacity at 90 days
• Data analysis plan:
  Primary and exploratory outcomes will be summarised as means, medians or percentages as appropriate with 95% confidence intervals. For the primary outcome, medication success will be claimed if the lower 95% confidence limit for the percentage achieving success is ≥ 70%, assessed at 90 days after Breztri/Trixeo initiation. Exploratory outcomes will be summarised separately for 90 days and 180 days. Additionally, an exploratory analysis will be carried out to try to identify factors associated with the primary outcome (early medication success) and with change in CAT score at 90 days.
• Summary results:
  The majority of patients initiating BGF experienced real-life medication success reflecting absence of severe cardiopulmonary events. These benefits were apparent after 90 days of treatment and sustained over 180 days.