Evidence in real world for Trixeo® Aerosphere™ Initiation in COPD (ENARXI)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The main aim of the study is to describe the characteristics of COPD patients when Trixeo® Aerosphere™ is initiated, based on data from the THIN® database.
• Data analysis plan:
  No hypotheses will be tested and no assumptions will be made in this analysis. Continuous variables will be described using mean and standard deviation for parametric variables, median and interquartile range for non-parametric variables. Ordinal, binomial and categorical variables will be described using numbers and proportions.