Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive pulmonary disease using health insurance claims data provided by Medical Data Vision Co., Ltd. in Japan (212606)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  TRELEGY ELLIPTA
• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE FUROATE

  UMECLIDINIUM

  VILANTEROL
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL08) vilanterol, umeclidinium bromide and fluticasone furoate

  vilanterol, umeclidinium bromide and fluticasone furoate
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Pneumonia

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:
  4000

Study design details

• Main study objective:
  Compare the occurrence of hospitalization due to community-acquired pneumonia (CAP) among patients with COPD who were incident users of Trelegy 100 or MITT. ; Hazard ratio (HR) will be calculated to investigate if the risk of CAP in Trelegy 100 group is not higher than a certain level (HR>3) compared to MITT group.
• Outcomes:
  Community-acquired pneumonia (CAP)
• Data analysis plan:
  Risk estimation