Patient characteristics and treatment pathways in patients with COPD initiated on ICS/LABA/LAMA and LABA/LAMA treatment

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  128003

Study design details

• Main study objective:
  To describe patient characteristics and 5-year treatment pathways prior to initiation on triple therapy and dual bronchodilator therapy
• Outcomes:
  Descriptive only – primary objective describes the patient characteristics of those initiating on: ICS/LABA/LAMA (free and fixed triple), LABA/LAMA (free and fixed dual bronchodilator), TRIMBOW (fixed triple) initiated as first ever triple therapy treatment and LABA/LAMA (fixed dual bronchodilator only), Descriptive only– secondary objective describes the treatment pathways in the 5 years prior to treatment initiation (defined as the maximal therapy prescribed within each 1-year period) for a 5 year period prior to initiation on ICS/LABA/LAMA, LABA/LAMA and TRIMBOW
• Data analysis plan:
  In order to describe patient characteristics, statistical differences between the patients split into cohorts will be assessed for those initiating on the following treatments between 2013 – 2023: A) ICS/LABA/LAMA (free and fixed triple) B) LABA/LAMA (free and fixed dual bronchodilator) C) Extra fine ICS/LABA/LAMA (fixed triple) initiated as first ever triple therapy treatment. D) LABA/LAMA (fixed dual bronchodilator only) Treatment pathways will be mapped in the 5 years prior to the date of treatment initiation. The pathways will be mapped as the sum of therapies prescribed during each 1 year period, with the 5 years prior to treatment initiation. Common treatment pathways will be identified based on the number of patients ≥1% of the total study population following a particular pathway. Pathways followed by <1% of patients will be grouped together and presented as other non-frequent pathways